Sample records for devices

  1. Semiconductor-based, large-area, flexible, electronic devices

    DOEpatents

    Goyal, Amit [Knoxville, TN

    2011-03-15

    Novel articles and methods to fabricate the same resulting in flexible, large-area, triaxially textured, single-crystal or single-crystal-like, semiconductor-based, electronic devices are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

  2. Semiconductor-based, large-area, flexible, electronic devices on {110}<100> oriented substrates

    DOEpatents

    Goyal, Amit

    2014-08-05

    Novel articles and methods to fabricate the same resulting in flexible, oriented, semiconductor-based, electronic devices on {110}<100> textured substrates are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

  3. [100] or [110] aligned, semiconductor-based, large-area, flexible, electronic devices

    DOEpatents

    Goyal, Amit

    2015-03-24

    Novel articles and methods to fabricate the same resulting in flexible, large-area, [100] or [110] textured, semiconductor-based, electronic devices are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

  4. {100}<100> or 45.degree.-rotated {100}<100>, semiconductor-based, large-area, flexible, electronic devices

    DOEpatents

    Goyal, Amit [Knoxville, TN

    2012-05-15

    Novel articles and methods to fabricate the same resulting in flexible, {100}<100> or 45.degree.-rotated {100}<100> oriented, semiconductor-based, electronic devices are disclosed. Potential applications of resulting articles are in areas of photovoltaic devices, flat-panel displays, thermophotovoltaic devices, ferroelectric devices, light emitting diode devices, computer hard disc drive devices, magnetoresistance based devices, photoluminescence based devices, non-volatile memory devices, dielectric devices, thermoelectric devices and quantum dot laser devices.

  5. 76 FR 45860 - In the Matter of Certain Electronic Devices, Including Wireless Communication Devices, Portable...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... electronic devices, including wireless communication devices, portable music and data processing devices, and... electronic devices, including wireless communication devices, portable music and data processing devices, and...

  6. Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture

    DOEpatents

    McCown, Steven H [Rigby, ID; Derr, Kurt W [Idaho Falls, ID; Rohde, Kenneth W [Idaho Falls, ID

    2012-05-08

    Wireless device monitoring methods, wireless device monitoring systems, and articles of manufacture are described. According to one embodiment, a wireless device monitoring method includes accessing device configuration information of a wireless device present at a secure area, wherein the device configuration information comprises information regarding a configuration of the wireless device, accessing stored information corresponding to the wireless device, wherein the stored information comprises information regarding the configuration of the wireless device, comparing the device configuration information with the stored information, and indicating the wireless device as one of authorized and unauthorized for presence at the secure area using the comparing.

  7. 16 CFR § 1507.9 - Toy smoke devices and flitter devices.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Toy smoke devices and flitter devices. Â... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

  8. 16 CFR 1507.9 - Toy smoke devices and flitter devices.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Toy smoke devices and flitter devices. 1507... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

  9. 16 CFR 1507.9 - Toy smoke devices and flitter devices.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Toy smoke devices and flitter devices. 1507... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

  10. 16 CFR 1507.9 - Toy smoke devices and flitter devices.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Toy smoke devices and flitter devices. 1507... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... fuse and firstfire upon ignition) during normal operation. (b) Toy smoke devices and flitter devices...

  11. 77 FR 58576 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ... Devices, Portable Music and Data Processing Devices, Computers, and Components Thereof; Institution of... communication devices, portable music and data processing devices, computers, and components thereof by reason... certain wireless communication devices, portable music and data processing devices, computers, and...

  12. 78 FR 34669 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-10

    ..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... importing wireless communication devices, portable music and data processing devices, and tablet computers... certain electronic devices, including wireless communication devices, portable music and data processing...

  13. 21 CFR 882.1560 - Skin potential measurement device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

  14. 21 CFR 882.1560 - Skin potential measurement device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

  15. 21 CFR 882.1560 - Skin potential measurement device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

  16. 21 CFR 882.1560 - Skin potential measurement device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Skin potential measurement device. 882.1560... (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential measurement device. (a) Identification. A skin potential measurement device is a general diagnostic device...

  17. 21 CFR 872.2060 - Jaw tracking device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device... Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.” [68 FR 67367, Dec. 2, 2003] ...

  18. 21 CFR 872.2050 - Dental sonography device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

  19. 21 CFR 872.2050 - Dental sonography device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

  20. 21 CFR 872.2050 - Dental sonography device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

  1. 21 CFR 872.2050 - Dental sonography device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

  2. 21 CFR 872.2050 - Dental sonography device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental sonography device. 872.2050 Section 872...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an...

  3. 21 CFR 872.6010 - Abrasive device and accessories.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6010 Abrasive device and accessories... crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive...

  4. 21 CFR 872.6010 - Abrasive device and accessories.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6010 Abrasive device and accessories... crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive...

  5. 21 CFR 872.6010 - Abrasive device and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6010 Abrasive device and accessories... crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive...

  6. 21 CFR 872.6010 - Abrasive device and accessories.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6010 Abrasive device and accessories... crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive...

  7. 21 CFR 872.6010 - Abrasive device and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6010 Abrasive device and accessories... crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive...

  8. Processes for multi-layer devices utilizing layer transfer

    DOEpatents

    Nielson, Gregory N; Sanchez, Carlos Anthony; Tauke-Pedretti, Anna; Kim, Bongsang; Cederberg, Jeffrey; Okandan, Murat; Cruz-Campa, Jose Luis; Resnick, Paul J

    2015-02-03

    A method includes forming a release layer over a donor substrate. A plurality of devices made of a first semiconductor material are formed over the release layer. A first dielectric layer is formed over the plurality of devices such that all exposed surfaces of the plurality of devices are covered by the first dielectric layer. The plurality of devices are chemically attached to a receiving device made of a second semiconductor material different than the first semiconductor material, the receiving device having a receiving substrate attached to a surface of the receiving device opposite the plurality of devices. The release layer is etched to release the donor substrate from the plurality of devices. A second dielectric layer is applied over the plurality of devices and the receiving device to mechanically attach the plurality of devices to the receiving device.

  9. 21 CFR 872.1740 - Caries detection device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Caries detection device. 872.1740 Section 872.1740...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1740 Caries detection device. (a) Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth...

  10. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

  11. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

  12. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

  13. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

  14. 21 CFR 886.1450 - Corneal radius measuring device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Corneal radius measuring device. 886.1450 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1450 Corneal radius measuring device. (a) Identification. A corneal radius measuring device is an AC-powered device intended to measure...

  15. 21 CFR 886.4360 - Ocular surgery irrigation device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

  16. 21 CFR 886.4360 - Ocular surgery irrigation device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

  17. 21 CFR 886.4360 - Ocular surgery irrigation device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

  18. 21 CFR 886.4360 - Ocular surgery irrigation device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

  19. 21 CFR 886.4360 - Ocular surgery irrigation device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

  20. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and retrieval...

  1. 21 CFR 872.1820 - Dental x-ray exposure alignment device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

  2. 21 CFR 872.1840 - Dental x-ray position indicating device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

  3. 21 CFR 872.1840 - Dental x-ray position indicating device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

  4. 21 CFR 872.1820 - Dental x-ray exposure alignment device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

  5. 21 CFR 872.1820 - Dental x-ray exposure alignment device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

  6. 21 CFR 872.1820 - Dental x-ray exposure alignment device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

  7. 21 CFR 872.1840 - Dental x-ray position indicating device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

  8. 21 CFR 872.1840 - Dental x-ray position indicating device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

  9. 21 CFR 872.1820 - Dental x-ray exposure alignment device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental x-ray exposure alignment device. 872.1820... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1820 Dental x-ray exposure alignment device. (a) Identification. A dental x-ray exposure alignment device is a device intended to position x...

  10. 21 CFR 872.1840 - Dental x-ray position indicating device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental x-ray position indicating device. 872.1840... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator...

  11. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

  12. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

  13. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

  14. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...

  15. 21 CFR 892.1610 - Diagnostic x-ray beam-limiting device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Diagnostic x-ray beam-limiting device. 892.1610... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1610 Diagnostic x-ray beam-limiting device. (a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a...

  16. 21 CFR 892.1610 - Diagnostic x-ray beam-limiting device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic x-ray beam-limiting device. 892.1610... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1610 Diagnostic x-ray beam-limiting device. (a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a...

  17. 21 CFR 892.1610 - Diagnostic x-ray beam-limiting device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Diagnostic x-ray beam-limiting device. 892.1610... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1610 Diagnostic x-ray beam-limiting device. (a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a...

  18. 21 CFR 892.1610 - Diagnostic x-ray beam-limiting device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Diagnostic x-ray beam-limiting device. 892.1610... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1610 Diagnostic x-ray beam-limiting device. (a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a...

  19. 21 CFR 892.1610 - Diagnostic x-ray beam-limiting device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Diagnostic x-ray beam-limiting device. 892.1610... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1610 Diagnostic x-ray beam-limiting device. (a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a...

  20. 21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

  1. 21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

  2. 21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

  3. 21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

  4. 21 CFR 864.9195 - Blood mixing devices and blood weighing devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood mixing devices and blood weighing devices... Manufacture Blood and Blood Products § 864.9195 Blood mixing devices and blood weighing devices. (a) Identification. A blood mixing device is a device intended for medical purposes that is used to mix blood or...

  5. 78 FR 16865 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-19

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... certain electronic devices, including wireless communication devices, portable music and data processing...

  6. Continuation of copper and levonorgestrel intrauterine devices: a retrospective cohort study.

    PubMed

    Phillips, Sharon J; Hofler, Lisa G; Modest, Anna M; Harvey, Lara F B; Wu, Lily H; Hacker, Michele R

    2017-07-01

    Studies conflict on whether the duration of use of the copper intrauterine device is longer than that of the levonorgestrel intrauterine device, and whether women who continue using intrauterine devices differ from those who discontinue. We sought to assess continuation rates and performance of levonorgestrel intrauterine devices compared with copper intrauterine devices over a 5-year period. We performed a retrospective cohort study of 1164 individuals who underwent intrauterine device placement at an urban academic medical center. The analysis focused on a comparison of continuation rates between those using levonorgestrel intrauterine device and copper intrauterine device, factors associated with discontinuation, and intrauterine device performance. We assessed the differences in continuation at discrete time points, pregnancy, and expulsion rates using χ 2 tests and calculated hazard ratios using a multivariable Cox model. Of 1164 women who underwent contraceptive intrauterine device insertion, 956 had follow-up data available. At 2 years, 64.9% of levonorgestrel intrauterine device users continued their device, compared with 57.7% of copper intrauterine device users (P = .11). At 4 years, continuation rates were 45.1% for levonorgestrel intrauterine device and 32.6% for copper intrauterine device (P < .01), and at 5 years continuation rates were 28.1% for levonorgestrel intrauterine device and 23.8% for copper intrauterine device (P = .33). Black race, primiparity, and age were positively associated with discontinuation; education was not. The hazard ratio for discontinuation of levonorgestrel intrauterine device compared with copper intrauterine device >4 years was 0.71 (95% confidence interval, 0.55-0.93) and >5 years was 0.82 (95% confidence interval, 0.64-1.05) after adjusting for race, age, parity, and education. Copper intrauterine device users were more likely to experience expulsion (10.2% copper intrauterine device vs 4.9% levonorgestrel intrauterine device, P < .01) over the study period and to become pregnant in the first year of use (1.6% copper intrauterine device vs 0.1% levonorgestrel intrauterine device, P < .01). We found a difference in continuation rates between levonorgestrel and copper intrauterine device users at 4 years but not at 5 years. Copper intrauterine device users were more likely to experience expulsion and pregnancy. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Continuation of copper and levonorgestrel intrauterine devices: a retrospective cohort study

    PubMed Central

    Phillips, Sharon J.; Hofler, Lisa G.; Modest, Anna M.; Harvey, Lara F. B.; Wu, Lily H.; Hacker, Michele R.

    2018-01-01

    Background Studies conflict on whether the duration of use of the copper intrauterine device is longer than that of the levonorgestrel intra-uterine device, and whether women who continue using intrauterine devices differ from those who discontinue. Objective We sought to assess continuation rates and performance of levonorgestrel intrauterine devices compared with copper intrauterine devices over a 5-year period. Study Design We performed a retrospective cohort study of 1164 individuals who underwent intrauterine device placement at an urban academic medical center. The analysis focused on a comparison of continuation rates between those using levonorgestrel intrauterine device and copper intrauterine device, factors associated with discontinuation, and intrauterine device performance. We assessed the differences in continuation at discrete time points, pregnancy, and expulsion rates using χ2 tests and calculated hazard ratios using a multivariable Cox model. Results Of 1164 women who underwent contraceptive intrauterine device insertion, 956 had follow-up data available. At 2 years, 64.9% of levonorgestrel intrauterine device users continued their device, compared with 57.7% of copper intrauterine device users (P = .11). At 4 years, continuation rates were 45.1% for levonorgestrel intrauterine device and 32.6% for copper intrauterine device (P < .01), and at 5 years continuation rates were 28.1% for levonorgestrel intrauterine device and 23.8% for copper intrauterine device (P = .33). Black race, primiparity, and age were positively associated with discontinuation; education was not. The hazard ratio for discontinuation of levonorgestrel intrauterine device compared with copper intrauterine device >4 years was 0.71 (95% confidence interval, 0.55–0.93) and >5 years was 0.82 (95% confidence interval, 0.64–1.05) after adjusting for race, age, parity, and education. Copper intrauterine device users were more likely to experience expulsion (10.2% copper intrauterine device vs 4.9% levonorgestrel intrauterine device, P < .01) over the study period and to become pregnant in the first year of use (1.6% copper intrauterine device vs 0.1% levonorgestrel intrauterine device, P < .01). Conclusion We found a difference in continuation rates between levonorgestrel and copper intrauterine device users at 4 years but not at 5 years. Copper intrauterine device users were more likely to experience expulsion and pregnancy. PMID:28315664

  8. Evaluation of tissue interactions with mechanical elements of a transscleral drug delivery device.

    PubMed

    Cohen, Sarah J; Chan, Robison V Paul; Keegan, Mark; Andreoli, Christopher M; Borenstein, Jeffrey T; Miller, Joan W; Gragoudas, Evangelos S

    2012-03-12

    The goal of this work was to evaluate tissue-device interactions due to implantation of a mechanically operated drug delivery system onto the posterior sclera. Two test devices were designed and fabricated to model elements of the drug delivery device-one containing a free-spinning ball bearing and the other encasing two articulating gears. Openings in the base of test devices modeled ports for drug passage from device to sclera. Porous poly(tetrafluoroethylene) (PTFE) membranes were attached to half of the gear devices to minimize tissue ingrowth through these ports. Test devices were sutured onto rabbit eyes for 10 weeks. Tissue-device interactions were evaluated histologically and mechanically after removal to determine effects on device function and changes in surrounding tissue. Test devices were generally well-tolerated during residence in the animal. All devices encouraged fibrous tissue formation between the sclera and the device, fibrous tissue encapsulation and invasion around the device, and inflammation of the conjunctiva. Gear devices encouraged significantly greater inflammation in all cases and a larger rate of tissue ingrowth. PTFE membranes prevented tissue invasion through the covered drug ports, though tissue migrated in through other smaller openings. The torque required to turn the mechanical elements increased over 1000 times for gear devices, but only on the order of 100 times for membrane-covered gear devices and less than 100 times for ball bearing devices. Maintaining a lower device profile, minimizing microscale motion on the eye surface and covering drug ports with a porous membrane may minimize inflammation, decreasing the risk of damage to surrounding tissues and minimizing disruption of device operation.

  9. 77 FR 60720 - Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data Processing Devices, and Tablet Computers... communication devices, portable music and data processing devices, and tablet computers, imported by Apple Inc...

  10. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

  11. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

  12. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

  13. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of medical...

  14. Release strategies for making transferable semiconductor structures, devices and device components

    DOEpatents

    Rogers, John A; Nuzzo, Ralph G; Meitl, Matthew; Ko, Heung Cho; Yoon, Jongseung; Menard, Etienne; Baca, Alfred J

    2014-11-25

    Provided are methods for making a device or device component by providing a multilayer structure having a plurality of functional layers and a plurality of release layers and releasing the functional layers from the multilayer structure by separating one or more of the release layers to generate a plurality of transferable structures. The transferable structures are printed onto a device substrate or device component supported by a device substrate. The methods and systems provide means for making high-quality and low-cost photovoltaic devices, transferable semiconductor structures, (opto-)electronic devices and device components.

  15. Release strategies for making transferable semiconductor structures, devices and device components

    DOEpatents

    Rogers, John A [Champaign, IL; Nuzzo, Ralph G [Champaign, IL; Meitl, Matthew [Raleigh, NC; Ko, Heung Cho [Urbana, IL; Yoon, Jongseung [Urbana, IL; Menard, Etienne [Durham, NC; Baca, Alfred J [Urbana, IL

    2011-04-26

    Provided are methods for making a device or device component by providing a multilayer structure having a plurality of functional layers and a plurality of release layers and releasing the functional layers from the multilayer structure by separating one or more of the release layers to generate a plurality of transferable structures. The transferable structures are printed onto a device substrate or device component supported by a device substrate. The methods and systems provide means for making high-quality and low-cost photovoltaic devices, transferable semiconductor structures, (opto-)electronic devices and device components.

  16. Release strategies for making transferable semiconductor structures, devices and device components

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rogers, John A.; Nuzzo, Ralph G.; Meitl, Matthew

    2016-05-24

    Provided are methods for making a device or device component by providing a multi layer structure having a plurality of functional layers and a plurality of release layers and releasing the functional layers from the multilayer structure by separating one or more of the release layers to generate a plurality of transferable structures. The transferable structures are printed onto a device substrate or device component supported by a device substrate. The methods and systems provide means for making high-quality and low-cost photovoltaic devices, transferable semiconductor structures, (opto-)electronic devices and device components.

  17. 21 CFR 872.1745 - Laser fluorescence caries detection device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Laser fluorescence caries detection device. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1745 Laser fluorescence caries detection device. (a) Identification. A laser fluorescence caries detection device is a laser, a...

  18. Extending Wi-Fi Direct for Automated Operations

    DTIC Science & Technology

    2015-03-01

    functionalities. These added functionalities include: automatic device discovery, a mutual awareness of capabilities between devices (inter-device capability ...functionalities include: automatic device discove1y, a mutual awareness of capabilities between devices (inter-device capability awareness...Figure 7. P2P Device GO Negotiation Request (The P2P IE includes P2P Capability , P2P Device Info, Group Owner Intent, Configuration Timeout, Listen

  19. 21 CFR 884.5360 - Contraceptive intrauterine device (IUD) and introducer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Contraceptive intrauterine device (IUD) and... Gynecological Therapeutic Devices § 884.5360 Contraceptive intrauterine device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is...

  20. 21 CFR 884.5360 - Contraceptive intrauterine device (IUD) and introducer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Contraceptive intrauterine device (IUD) and... Gynecological Therapeutic Devices § 884.5360 Contraceptive intrauterine device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is...

  1. 21 CFR 884.5360 - Contraceptive intrauterine device (IUD) and introducer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Contraceptive intrauterine device (IUD) and... Gynecological Therapeutic Devices § 884.5360 Contraceptive intrauterine device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is...

  2. 21 CFR 884.5360 - Contraceptive intrauterine device (IUD) and introducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Contraceptive intrauterine device (IUD) and... Gynecological Therapeutic Devices § 884.5360 Contraceptive intrauterine device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is...

  3. 21 CFR 884.5360 - Contraceptive intrauterine device (IUD) and introducer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Contraceptive intrauterine device (IUD) and... Gynecological Therapeutic Devices § 884.5360 Contraceptive intrauterine device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is...

  4. 21 CFR 872.2060 - Jaw tracking device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

  5. 21 CFR 872.2060 - Jaw tracking device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

  6. 21 CFR 872.2060 - Jaw tracking device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

  7. 21 CFR 872.2060 - Jaw tracking device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Jaw tracking device. 872.2060 Section 872.2060 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device...

  8. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  9. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  10. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  11. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  12. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  13. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Bolenbaugh, Jonathan M.; Naqi, Syed

    A method to operate a clutch device in an electro-mechanical transmission mechanically-operatively coupled to an internal combustion engine and at least one electric machine includes, in response to a failure condition detected within a flow control device configured to facilitate flow of hydraulic fluid for operating the clutch device, selectively preventing the flow of hydraulic fluid from entering the flow control device and feeding the clutch device. Synchronization of the clutch device is initiated when the clutch device is intended for activation, and only if the clutch device is synchronized, the flow of hydraulic fluid is selectively permitted to entermore » the flow control device to activate the clutch device.« less

  14. Evaluation of an investigational wearable injector in healthy human volunteers.

    PubMed

    Torjman, Marc C; Machnicki, Robert; Lessin, Jennifer; Loeum, Channy; Steinberger, Douglas; Mycroft, Sarah; Joseph, Jeffrey I

    2017-01-01

    Introduction of a wearable device for subcutaneous delivery of larger volume bolus injections would encourage patient compliance and reduce the burden on healthcare services. With one such wearable device commercially available, this study examined the safety and functionality of an investigational device in volunteers. Four devices were applied to the subject's abdomen: 1) Investigational Device, 2) Investigational Device: subject movement, 3) Control Device: FDA-cleared syringe driver with FDA-cleared infusion set, 4) Control Device: FDA-cleared syringe driver attached to investigational device. Three milliliters of saline were infused through the four devices over 3 minutes. 84 devices were applied to 21 subjects. Three milliliters of saline were safely delivered subcutaneously from the investigational and control devices. Two control devices had occlusions and in each case the pump reached its high pressure limit of 12 psi. VAS pain measurements showed minimal pain for all subjects. Pain scores were significantly (p < 0.001) higher than baseline at the end of injection: mean pain level ranged from 2.0-22.0 mm. The investigational device performed as intended with minimal pain during needle insertion and infusion, and no leaking of fluid at the skin puncture site. Two occlusions occurred with the control devices.

  15. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... and 11, 2012, the committee will discuss general issues related to medical devices intended for obese...

  16. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...

  17. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

  18. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

  19. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

  20. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical device data system. 880.6310 Section 880... Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system (MDDS...

  1. 76 FR 29006 - In the Matter of Certain Motion-Sensitive Sound Effects Devices and Image Display Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ... Effects Devices and Image Display Devices and Components and Products Containing Same; Notice of... United States after importation of certain motion-sensitive sound effects devices and image display... devices and image display devices and components and products containing same that infringe one or more of...

  2. CONTROL LIMITER DEVICE

    DOEpatents

    DeShong, J.A.

    1960-03-01

    A control-limiting device for monltoring a control system is described. The system comprises a conditionsensing device, a condition-varying device exerting a control over the condition, and a control means to actuate the condition-varying device. A control-limiting device integrates the total movement or other change of the condition-varying device over any interval of time during a continuum of overlapping periods of time, and if the tothl movement or change of the condition-varying device exceeds a preset value, the control- limiting device will switch the control of the operated apparatus from automatic to manual control.

  3. Eager protocol on a cache pipeline dataflow

    DOEpatents

    Ohmacht, Martin; Sugavanam, Krishnan

    2012-11-13

    A master device sends a request to communicate with a slave device to a switch. The master device waits for a period of cycles the switch takes to decide whether the master device can communicate with the slave device, and the master device sends data associated with the request to communicate at least after the period of cycles has passed since the master device sent the request to communicate to the switch without waiting to receive an acknowledgment from the switch that the master device can communicate with the slave device.

  4. Two Different Maintenance Strategies in the Hospital Environment: Preventive Maintenance for Older Technology Devices and Predictive Maintenance for Newer High-Tech Devices.

    PubMed

    Sezdi, Mana

    2016-01-01

    A maintenance program generated through the consideration of characteristics and failures of medical equipment is an important component of technology management. However, older technology devices and newer high-tech devices cannot be efficiently managed using the same strategies because of their different characteristics. This study aimed to generate a maintenance program comprising two different strategies to increase the efficiency of device management: preventive maintenance for older technology devices and predictive maintenance for newer high-tech devices. For preventive maintenance development, 589 older technology devices were subjected to performance verification and safety testing (PVST). For predictive maintenance development, the manufacturers' recommendations were used for 134 high-tech devices. These strategies were evaluated in terms of device reliability. This study recommends the use of two different maintenance strategies for old and new devices at hospitals in developing countries. Thus, older technology devices that applied only corrective maintenance will be included in maintenance like high-tech devices.

  5. Two Different Maintenance Strategies in the Hospital Environment: Preventive Maintenance for Older Technology Devices and Predictive Maintenance for Newer High-Tech Devices

    PubMed Central

    Sezdi, Mana

    2016-01-01

    A maintenance program generated through the consideration of characteristics and failures of medical equipment is an important component of technology management. However, older technology devices and newer high-tech devices cannot be efficiently managed using the same strategies because of their different characteristics. This study aimed to generate a maintenance program comprising two different strategies to increase the efficiency of device management: preventive maintenance for older technology devices and predictive maintenance for newer high-tech devices. For preventive maintenance development, 589 older technology devices were subjected to performance verification and safety testing (PVST). For predictive maintenance development, the manufacturers' recommendations were used for 134 high-tech devices. These strategies were evaluated in terms of device reliability. This study recommends the use of two different maintenance strategies for old and new devices at hospitals in developing countries. Thus, older technology devices that applied only corrective maintenance will be included in maintenance like high-tech devices. PMID:27195666

  6. Radiology of cardiac devices and their complications

    PubMed Central

    Dipoce, J; Spindola-Franco, H

    2015-01-01

    This article familiarizes the reader with several different cardiac devices including pacemakers and implantable cardioverter defibrillators, intra-aortic balloon pumps, ventricular assist devices, valve replacements and repairs, shunt-occluding devices and passive constraint devices. Many cardiac devices are routinely encountered in clinical practice. Other devices are in the early stages of development, but circumstances suggest that they too will become commonly found. The radiologist must be familiar with these devices and their complications. PMID:25411826

  7. Wireless device monitoring systems and monitoring devices, and associated methods

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    McCown, Steven H; Derr, Kurt W; Rohde, Kenneth W

    Wireless device monitoring systems and monitoring devices include a communications module for receiving wireless communications of a wireless device. Processing circuitry is coupled with the communications module and configured to process the wireless communications to determine whether the wireless device is authorized or unauthorized to be present at the monitored area based on identification information of the wireless device. Methods of monitoring for the presence and identity of wireless devices are also provided.

  8. Localized electrical fine tuning of passive microwave and radio frequency devices

    DOEpatents

    Findikoglu, Alp T.

    2001-04-10

    A method and apparatus for the localized electrical fine tuning of passive multiple element microwave or RF devices in which a nonlinear dielectric material is deposited onto predetermined areas of a substrate containing the device. An appropriate electrically conductive material is deposited over predetermined areas of the nonlinear dielectric and the signal line of the device for providing electrical contact with the nonlinear dielectric. Individual, adjustable bias voltages are applied to the electrically conductive material allowing localized electrical fine tuning of the devices. The method of the present invention can be applied to manufactured devices, or can be incorporated into the design of the devices so that it is applied at the time the devices are manufactured. The invention can be configured to provide localized fine tuning for devices including but not limited to coplanar waveguides, slotline devices, stripline devices, and microstrip devices.

  9. Processing module operating methods, processing modules, and communications systems

    DOEpatents

    McCown, Steven Harvey; Derr, Kurt W.; Moore, Troy

    2014-09-09

    A processing module operating method includes using a processing module physically connected to a wireless communications device, requesting that the wireless communications device retrieve encrypted code from a web site and receiving the encrypted code from the wireless communications device. The wireless communications device is unable to decrypt the encrypted code. The method further includes using the processing module, decrypting the encrypted code, executing the decrypted code, and preventing the wireless communications device from accessing the decrypted code. Another processing module operating method includes using a processing module physically connected to a host device, executing an application within the processing module, allowing the application to exchange user interaction data communicated using a user interface of the host device with the host device, and allowing the application to use the host device as a communications device for exchanging information with a remote device distinct from the host device.

  10. Wafer bonded epitaxial templates for silicon heterostructures

    DOEpatents

    Atwater, Jr., Harry A.; Zahler, James M [Pasadena, CA; Morral, Anna Fontcubera I [Paris, FR

    2008-03-11

    A heterostructure device layer is epitaxially grown on a virtual substrate, such as an InP/InGaAs/InP double heterostructure. A device substrate and a handle substrate form the virtual substrate. The device substrate is bonded to the handle substrate and is composed of a material suitable for fabrication of optoelectronic devices. The handle substrate is composed of a material suitable for providing mechanical support. The mechanical strength of the device and handle substrates is improved and the device substrate is thinned to leave a single-crystal film on the virtual substrate such as by exfoliation of a device film from the device substrate. An upper portion of the device film exfoliated from the device substrate is removed to provide a smoother and less defect prone surface for an optoelectronic device. A heterostructure is epitaxially grown on the smoothed surface in which an optoelectronic device may be fabricated.

  11. Photoelectrochemically driven self-assembly method

    DOEpatents

    Nielson, Gregory N.; Okandan, Murat

    2017-01-17

    Various technologies described herein pertain to assembling electronic devices into a microsystem. The electronic devices are disposed in a solution. Light can be applied to the electronic devices in the solution. The electronic devices can generate currents responsive to the light applied to the electronic devices in the solution, and the currents can cause electrochemical reactions that functionalize regions on surfaces of the electronic devices. Additionally or alternatively, the light applied to the electronic devices in the solution can cause the electronic devices to generate electric fields, which can orient the electronic devices and/or induce movement of the electronic devices with respect to a receiving substrate. Further, electrodes on a receiving substrate can be biased to attract and form connections with the electronic devices having the functionalized regions on the surfaces. The microsystem can include the receiving substrate and the electronic devices connected to the receiving substrate.

  12. Wafer bonded epitaxial templates for silicon heterostructures

    NASA Technical Reports Server (NTRS)

    Atwater, Harry A., Jr. (Inventor); Zahler, James M. (Inventor); Morral, Anna Fontcubera I (Inventor)

    2008-01-01

    A heterostructure device layer is epitaxially grown on a virtual substrate, such as an InP/InGaAs/InP double heterostructure. A device substrate and a handle substrate form the virtual substrate. The device substrate is bonded to the handle substrate and is composed of a material suitable for fabrication of optoelectronic devices. The handle substrate is composed of a material suitable for providing mechanical support. The mechanical strength of the device and handle substrates is improved and the device substrate is thinned to leave a single-crystal film on the virtual substrate such as by exfoliation of a device film from the device substrate. An upper portion of the device film exfoliated from the device substrate is removed to provide a smoother and less defect prone surface for an optoelectronic device. A heterostructure is epitaxially grown on the smoothed surface in which an optoelectronic device may be fabricated.

  13. Event-recording devices with identification codes

    NASA Technical Reports Server (NTRS)

    Watters, David G. (Inventor); Huestis, David L. (Inventor); Bahr, Alfred J. (Inventor); Vidmar, Robert J. (Inventor)

    2003-01-01

    A recording device allows wireless interrogation to determine its identity and its state. The state indicates whether one or more physical or chemical events have taken place. In effect, the one or more physical or chemical events are recorded by the device. The identity of the device allows it to be distinguished from a number of similar devices. The recording device may be used in an array of devices that allows wireless probing by an interrogation unit. When probed, each device tells the interrogator who it is and what state it is in. The devices allow multiple use and the interrogator may use a logical reset to determine the state of each device. The interrogator can thus easily identify particular items in an array that have reached a particular condition. The device may record the status of each device in a database to maintain a history for each.

  14. Evaluation of Tissue Interactions with Mechanical Elements of a Transscleral Drug Delivery Device

    PubMed Central

    Cohen, Sarah J.; Chan, Robison V. Paul; Keegan, Mark; Andreoli, Christopher M.; Borenstein, Jeffrey T.; Miller, Joan W.; Gragoudas, Evangelos S.

    2012-01-01

    The goal of this work was to evaluate tissue-device interactions due to implantation of a mechanically operated drug delivery system onto the posterior sclera. Two test devices were designed and fabricated to model elements of the drug delivery device—one containing a free-spinning ball bearing and the other encasing two articulating gears. Openings in the base of test devices modeled ports for drug passage from device to sclera. Porous poly(tetrafluoroethylene) (PTFE) membranes were attached to half of the gear devices to minimize tissue ingrowth through these ports. Test devices were sutured onto rabbit eyes for 10 weeks. Tissue-device interactions were evaluated histologically and mechanically after removal to determine effects on device function and changes in surrounding tissue. Test devices were generally well-tolerated during residence in the animal. All devices encouraged fibrous tissue formation between the sclera and the device, fibrous tissue encapsulation and invasion around the device, and inflammation of the conjunctiva. Gear devices encouraged significantly greater inflammation in all cases and a larger rate of tissue ingrowth. PTFE membranes prevented tissue invasion through the covered drug ports, though tissue migrated in through other smaller openings. The torque required to turn the mechanical elements increased over 1000 times for gear devices, but only on the order of 100 times for membrane-covered gear devices and less than 100 times for ball bearing devices. Maintaining a lower device profile, minimizing microscale motion on the eye surface and covering drug ports with a porous membrane may minimize inflammation, decreasing the risk of damage to surrounding tissues and minimizing disruption of device operation. PMID:24300189

  15. What people know about electronic devices: A descriptive study

    NASA Astrophysics Data System (ADS)

    Kieras, D. E.

    1982-10-01

    Informal descriptive results on the nature of people's natural knowledge of electronic devices are presented. Expert and nonexpert subjects were given an electronic device to examine and describe orally. The devices ranged from familiar everyday devices, to those familiar only to the expert, to unusual devices unfamiliar even to an expert. College students were asked to describe everyday devices from memory. The results suggest that device knowledge consists of the major categories of what the device is for, how it is used, its structure in terms of subdevices, its physical layout, how it works, and its behavior. A preliminary theoretical framework for device knowledge is that it consists of a hierarchy of schemas, corresponding to a hierarchial decomposition of the device into subdevices, with each level containing the major categories of information.

  16. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS-100 L/R, sponsored by Glaukos Corp. The device is...

  17. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ...] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY... an amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee would be held on September...

  18. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

  19. Hardware device binding and mutual authentication

    DOEpatents

    Hamlet, Jason R; Pierson, Lyndon G

    2014-03-04

    Detection and deterrence of device tampering and subversion by substitution may be achieved by including a cryptographic unit within a computing device for binding multiple hardware devices and mutually authenticating the devices. The cryptographic unit includes a physically unclonable function ("PUF") circuit disposed in or on the hardware device, which generates a binding PUF value. The cryptographic unit uses the binding PUF value during an enrollment phase and subsequent authentication phases. During a subsequent authentication phase, the cryptographic unit uses the binding PUF values of the multiple hardware devices to generate a challenge to send to the other device, and to verify a challenge received from the other device to mutually authenticate the hardware devices.

  20. 78 FR 1247 - Certain Electronic Devices, Including Wireless Communication Devices, Tablet Computers, Media...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Wireless Communication Devices, Tablet Computers, Media Players, and Televisions, and Components Thereof... devices, including wireless communication devices, tablet computers, media players, and televisions, and... wireless communication devices, tablet computers, media players, and televisions, and components thereof...

  1. Tracking down a solution: exploring the acceptability and value of wearable GPS devices for older persons, individuals with a disability and their support persons.

    PubMed

    Williamson, Brittany; Aplin, Tammy; de Jonge, Desleigh; Goyne, Matthew

    2017-11-01

    To explore the acceptability and value of three wearable GPS devices for older persons and individuals with a disability and safety concerns when accessing the community. This pilot study explored six wearers' and their support persons' experience of using three different wearable GPS devices (a pendant, watch, and mini GPS phone), each for a two-week period. Participants identified safety as the main value of using a wearable GPS device. The acceptability and value of these devices was strongly influenced by device features, ease of use, cost, appearance, the reliability of the GPS coordinates, the wearer's health condition and the users familiarity with technology. Overall, participants indicated that they preferred the pendant. Wearable GPS devices are potentially useful in providing individuals who have safety concerns with reassurance and access to assistance as required. To ensure successful utilization, future device design and device selection should consider the user's familiarity with technology and their health condition. This study also revealed that not all wearable GPS devices provide continuous location tracking. It is therefore critical to ensure that the device's location tracking functions address the wearer's requirements and reason for using the device. Implications for Rehabilitation The acceptability and usability of wearable GPS devices is strongly influenced by the device features, ease of use, cost, appearance, the reliability of the device to provide accurate and timely GPS coordinates, as well as the health condition of the wearer and their familiarity with technology. Wearable GPS devices need to be simple to use and support and training is essential to ensure they are successfully utilized. Not all wearable GPS devices provide continuous location tracking and accuracy of location is impacted by line of sight to satellites. Therefore, care needs to be taken when choosing a suitable device, to ensure that the device's location tracking features are based on the wearer's requirements and value behind using the device.

  2. Techniques for trans-catheter retrieval of embolized Nit-Occlud® PDA-R and ASD-R devices.

    PubMed

    Sinha, Sanjay; Levi, Daniel; Peirone, Alejandro; Pedra, Carlos

    2018-02-15

    Nit-Occlud ® (atrial septal defect) ASD-R and (patent ductus arteriosus) PDA-R devices are used outside the United States for percutaneous closure of the patent ductus arteriosus and atrial septal defects. When embolization occurs, these devices have been difficult to retrieve. Bench simulations of retrieval of PDA-R and ASD-R devices were performed in a vascular model. Retrieval of each device was attempted using snare techniques or with bioptome forceps with a range of devices. The same devices were then intentionally embolized in an animal model. Retrieval methods were systematically tested in a range of sheath sizes, and graded in terms of difficulty and retrieval time. Devices that were grasped by the bioptome in the center of the proximal part of the devices were easily retrieved in both models. Bench studies determined the minimum sheath sizes needed for retrieval of each device with this method. In general sheathes two french sizes greater than the delivery sheath were successful with this technique. Three out of the four PDA-R devices were successfully retrieved in vivo. Two were retrieved by grasping the middle of the PA end of the PDA-R device with a Maslanka bioptome and one small PDA-R device was retrieved using a 10 mm Snare. Four of the five ASD-R devices were retrieved successfully grasping the right atrial ASD-R disc or by passing a wire through the device and snaring this loop. For ASD-R 28 and 30 mm devices, a double bioptome technique was needed to retrieve the device. ASD-R and PDA-R devices can be successfully retrieved in the catheterization lab. It is critical to grab the center portion of the right atrial disc of the ASD-R device or pulmonary portion of the PDA-R device and to use adequately sized sheathes. © 2018 Wiley Periodicals, Inc.

  3. Applications and Methods of Operating a Three-dimensional Nano-electro-mechanical Resonator and Related Devices

    NASA Technical Reports Server (NTRS)

    Kaul, Anupama B. (Inventor); Epp, Larry W. (Inventor); Bagge, Leif (Inventor)

    2013-01-01

    Carbon nanofiber resonator devices, methods for use, and applications of said devices are disclosed. Carbon nanofiber resonator devices can be utilized in or as high Q resonators. Resonant frequency of these devices is a function of configuration of various conducting components within these devices. Such devices can find use, for example, in filtering and chemical detection.

  4. Current state of medical device nomenclature and taxonomy systems in the UK: spotlight on GMDN and SNOMED CT

    PubMed Central

    White, Judith; Carolan-Rees, Grace

    2013-01-01

    A standardised terminology for describing medical devices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medical devices regulations mandate the use of such a system. This article reviews two important classification systems for medical devices in the UK. The Global Medical Device Nomenclature (GMDN) provides a classification system specifically for medical devices and diagnostics, and facilitates data exchange between manufacturers and regulators. SNOMED CT is the terminology of choice in the NHS for communicating, sharing and storing information about patients’ healthcare episodes. Harmonisation of GMDN and SNOMED CT will encourage use of single terminology throughout the lifetime of a device; from regulatory approval through clinical use and post-marketing surveillance. Manufacturers will be required to register medical devices with a European device database (Eudamed) and to fit certain devices with a Unique Device Identifier; both are efforts to improve transparency and traceability of medical devices. Successful implementation of these elements depends on having a consistent nomenclature for medical devices. PMID:23885299

  5. Examining the Relationship between Parental Involvement and Mobile Technology Use

    NASA Astrophysics Data System (ADS)

    Flowers, Toinette M.

    Understanding how mobile devices can enhance parent/teacher communication is important because parents play an important part in their children's learning. Research on parents' use of mobile devices to communicate with their children's teachers is limited. The purpose of this cross-sectional correlational study was to determine the relationships between parents' (a) knowledge of using mobile devices, (b) general use of mobile devices, (c) purpose for using mobile devices, (d) perceived ease of using mobile devices, (e) perceived usefulness of mobile devices, (f) attitude toward using mobile devices, and (g) use of mobile devices to communicate with teachers. The study was informed by the technology acceptance model and used a participant pool of 73 parents of high school students attending a Title I high school in a large Midwestern city in the United States. Data were collected using an online survey and analyzed using Pearson's correlations. The study results indicate significant correlations between parents' use of mobile devices to communicate with teachers and knowledge of using mobile devices, purpose for using mobile devices, perceived ease of using mobile devices, perceived usefulness of mobile devices, and attitudes toward using mobile devices. These findings suggest that parental use of mobile devices to communicate with teachers can be enhanced by administrators and school personnel using strategies that consider parents' and the school culture. Social implication includes sharing the results of this study with district and school administrators who have the power to implement programs that encourage and support the use of mobile devices as a communication tool between parents and teachers, therefore increasing parental involvement and ultimately student academic success.

  6. 21 CFR 882.5050 - Biofeedback device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Biofeedback device. 882.5050 Section 882.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5050 Biofeedback device. (a...

  7. 21 CFR 872.3660 - Impression material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3660 Impression material. (a) Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed... device is intended to provide models for study and for production of restorative prosthetic devices, such...

  8. 21 CFR 872.3660 - Impression material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3660 Impression material. (a) Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed... device is intended to provide models for study and for production of restorative prosthetic devices, such...

  9. 78 FR 24775 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Commission Decision... importation of certain wireless communication devices, portable music and data processing devices, computers...

  10. 78 FR 12785 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Commission Decision... importation of certain wireless communication devices, portable music and data processing devices, computers...

  11. Three fundamental devices in one: a reconfigurable multifunctional device in two-dimensional WSe2

    NASA Astrophysics Data System (ADS)

    Dhakras, Prathamesh; Agnihotri, Pratik; Lee, Ji Ung

    2017-06-01

    The three pillars of semiconductor device technologies are (1) the p-n diode, (2) the metal-oxide-semiconductor field-effect transistor and (3) the bipolar junction transistor. They have enabled the unprecedented growth in the field of information technology that we see today. Until recently, the technological revolution for better, faster and more efficient devices has been governed by scaling down the device dimensions following Moore’s Law. With the slowing of Moore’s law, there is a need for alternative materials and computing technologies that can continue the advancement in functionality. Here, we describe a single, dynamically reconfigurable device that implements these three fundamental device functions. The device uses buried gates to achieve n- and p-channels and fits into a larger effort to develop devices with enhanced functionalities, including logic functions, over device scaling. As they are all surface conducting devices, we use one material parameter, the interface trap density of states, to describe the key figure-of-merit of each device.

  12. Content analysis of Australian direct-to-consumer websites for emerging breast cancer imaging devices.

    PubMed

    Vreugdenburg, Thomas D; Laurence, Caroline O; Willis, Cameron D; Mundy, Linda; Hiller, Janet E

    2014-09-01

    To describe the nature and frequency of information presented on direct-to-consumer websites for emerging breast cancer imaging devices. Content analysis of Australian website advertisements from 2 March 2011 to 30 March 2012, for three emerging breast cancer imaging devices: digital infrared thermal imaging, electrical impedance scanning and electronic palpation imaging. Type of imaging offered, device safety, device performance, application of device, target population, supporting evidence and comparator tests. Thirty-nine unique Australian websites promoting a direct-to-consumer breast imaging device were identified. Despite a lack of supporting evidence, 22 websites advertised devices for diagnosis, 20 advertised devices for screening, 13 advertised devices for prevention and 13 advertised devices for identifying breast cancer risk factors. Similarly, advertised ranges of diagnostic sensitivity (78%-99%) and specificity (44%-91%) were relatively high compared with published literature. Direct comparisons with conventional screening tools that favoured the new device were highly prominent (31 websites), and one-third of websites (12) explicitly promoted their device as a suitable alternative. Australian websites for emerging breast imaging devices, which are also available internationally, promote the use of such devices as safe and effective solutions for breast cancer screening and diagnosis in a range of target populations. Many of these claims are not supported by peer-reviewed evidence, raising questions about the manner in which these devices and their advertising material are regulated, particularly when they are promoted as direct alternatives to established screening interventions.

  13. Lossless hybridization between photovoltaic and thermoelectric devices.

    PubMed

    Park, Kwang-Tae; Shin, Sun-Mi; Tazebay, Abdullah S; Um, Han-Don; Jung, Jin-Young; Jee, Sang-Won; Oh, Min-Wook; Park, Su-Dong; Yoo, Bongyoung; Yu, Choongho; Lee, Jung-Ho

    2013-01-01

    The optimal hybridization of photovoltaic (PV) and thermoelectric (TE) devices has long been considered ideal for the efficient harnessing solar energy. Our hybrid approach uses full spectrum solar energy via lossless coupling between PV and TE devices while collecting waste energy from thermalization and transmission losses from PV devices. Achieving lossless coupling makes the power output from the hybrid device equal to the sum of the maximum power outputs produced separately from individual PV and TE devices. TE devices need to have low internal resistances enough to convey photo-generated currents without sacrificing the PV fill factor. Concomitantly, a large number of p-n legs are preferred to drive a high Seebeck voltage in TE. Our simple method of attaching a TE device to a PV device has greatly improved the conversion efficiency and power output of the PV device (~30% at a 15°C temperature gradient across a TE device).

  14. Lossless hybridization between photovoltaic and thermoelectric devices

    PubMed Central

    Park, Kwang-Tae; Shin, Sun-Mi; Tazebay, Abdullah S.; Um, Han-Don; Jung, Jin-Young; Jee, Sang-Won; Oh, Min-Wook; Park, Su-Dong; Yoo, Bongyoung; Yu, Choongho; Lee, Jung-Ho

    2013-01-01

    The optimal hybridization of photovoltaic (PV) and thermoelectric (TE) devices has long been considered ideal for the efficient harnessing solar energy. Our hybrid approach uses full spectrum solar energy via lossless coupling between PV and TE devices while collecting waste energy from thermalization and transmission losses from PV devices. Achieving lossless coupling makes the power output from the hybrid device equal to the sum of the maximum power outputs produced separately from individual PV and TE devices. TE devices need to have low internal resistances enough to convey photo-generated currents without sacrificing the PV fill factor. Concomitantly, a large number of p-n legs are preferred to drive a high Seebeck voltage in TE. Our simple method of attaching a TE device to a PV device has greatly improved the conversion efficiency and power output of the PV device (~30% at a 15°C temperature gradient across a TE device). PMID:23820973

  15. 21 CFR 882.4250 - Cryogenic surgical device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cryogenic surgical device. 882.4250 Section 882.4250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4250 Cryogenic surgical device...

  16. 21 CFR 882.4250 - Cryogenic surgical device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cryogenic surgical device. 882.4250 Section 882.4250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Surgical Devices § 882.4250 Cryogenic surgical device...

  17. 21 CFR 872.1870 - Sulfide detection device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Sulfide detection device. 872.1870 Section 872.1870 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1870 Sulfide detection device. (a) Identification...

  18. 21 CFR 872.1740 - Caries detection device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Caries detection device. 872.1740 Section 872.1740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1740 Caries detection device. (a) Identification...

  19. 21 CFR 872.1740 - Caries detection device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Caries detection device. 872.1740 Section 872.1740 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1740 Caries detection device. (a) Identification...

  20. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ...] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot... Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and...

  1. 21 CFR 866.2580 - Gas-generating device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gas-generating device. 866.2580 Section 866.2580 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2580 Gas-generating device...

  2. 21 CFR 866.2580 - Gas-generating device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Gas-generating device. 866.2580 Section 866.2580 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2580 Gas-generating device...

  3. 21 CFR 866.2580 - Gas-generating device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Gas-generating device. 866.2580 Section 866.2580 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2580 Gas-generating device...

  4. 21 CFR 866.2580 - Gas-generating device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Gas-generating device. 866.2580 Section 866.2580 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2580 Gas-generating device...

  5. 21 CFR 866.2580 - Gas-generating device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Gas-generating device. 866.2580 Section 866.2580 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2580 Gas-generating device...

  6. 77 FR 52759 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Notice of... communication devices, portable music and data processing devices, computers and components thereof by reason of...

  7. 77 FR 51571 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-24

    ... Music and Data Processing Devices, Computers, and Components Thereof; Notice of Receipt of Complaint... complaint entitled Wireless Communication Devices, Portable Music and Data Processing Devices, Computers..., portable music and data processing devices, computers, and components thereof. The complaint names as...

  8. 21 CFR 874.5840 - Antistammering device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Antistammering device. 874.5840 Section 874.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5840 Antistammering device. (a...

  9. 21 CFR 874.5840 - Antistammering device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Antistammering device. 874.5840 Section 874.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5840 Antistammering device. (a...

  10. 21 CFR 874.5840 - Antistammering device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Antistammering device. 874.5840 Section 874.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5840 Antistammering device. (a...

  11. 21 CFR 874.5840 - Antistammering device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Antistammering device. 874.5840 Section 874.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5840 Antistammering device. (a...

  12. 21 CFR 810.10 - Cease distribution and notification order.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810... usual name of the device; (iii) The model, catalog, or product code numbers of the device; and (iv) The... opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device...

  13. 21 CFR 810.10 - Cease distribution and notification order.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810... usual name of the device; (iii) The model, catalog, or product code numbers of the device; and (iv) The... opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device...

  14. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Contraceptive tubal occlusion device (TOD) and... Gynecological Therapeutic Devices § 884.5380 Contraceptive tubal occlusion device (TOD) and introducer. (a) Identification. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a...

  15. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Contraceptive tubal occlusion device (TOD) and... Gynecological Therapeutic Devices § 884.5380 Contraceptive tubal occlusion device (TOD) and introducer. (a) Identification. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a...

  16. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Contraceptive tubal occlusion device (TOD) and... Gynecological Therapeutic Devices § 884.5380 Contraceptive tubal occlusion device (TOD) and introducer. (a) Identification. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a...

  17. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Contraceptive tubal occlusion device (TOD) and... Gynecological Therapeutic Devices § 884.5380 Contraceptive tubal occlusion device (TOD) and introducer. (a) Identification. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a...

  18. 21 CFR 884.5380 - Contraceptive tubal occlusion device (TOD) and introducer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Contraceptive tubal occlusion device (TOD) and... Gynecological Therapeutic Devices § 884.5380 Contraceptive tubal occlusion device (TOD) and introducer. (a) Identification. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a...

  19. Integrated device architectures for electrochromic devices

    DOEpatents

    Frey, Jonathan Mack; Berland, Brian Spencer

    2015-04-21

    This disclosure describes systems and methods for creating monolithically integrated electrochromic devices which may be a flexible electrochromic device. Monolithic integration of thin film electrochromic devices may involve the electrical interconnection of multiple individual electrochromic devices through the creation of specific structures such as conductive pathway or insulating isolation trenches.

  20. 21 CFR 892.1670 - Spot-film device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

  1. 21 CFR 892.1670 - Spot-film device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

  2. 21 CFR 892.1670 - Spot-film device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

  3. 21 CFR 892.1670 - Spot-film device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

  4. 76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ...] Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical Device... public meeting entitled ``510(k) Implementation: Discussion of an Online Repository of Medical Device... establish an online public repository of medical device labeling and strategies for displaying device...

  5. 76 FR 28689 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    .... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...

  6. 21 CFR 892.1670 - Spot-film device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Spot-film device. 892.1670 Section 892.1670 Food... DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1670 Spot-film device. (a) Identification. A spot-film... medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy. (b...

  7. 47 CFR 2.801 - Radiofrequency device defined.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Radiofrequency device defined. 2.801 Section 2... MATTERS; GENERAL RULES AND REGULATIONS Marketing of Radio-frequency Devices § 2.801 Radiofrequency device defined. As used in this part, a radiofrequency device is any device which in its operation is capable of...

  8. 21 CFR 886.4170 - Cryophthalmic unit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4170 Cryophthalmic unit. (a) Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove...

  9. 21 CFR 874.5370 - Tongs antichoke device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Tongs antichoke device. 874.5370 Section 874.5370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5370 Tongs antichoke device. (a...

  10. 21 CFR 874.5350 - Suction antichoke device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Suction antichoke device. 874.5350 Section 874.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5350 Suction antichoke device. (a...

  11. 21 CFR 874.5350 - Suction antichoke device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Suction antichoke device. 874.5350 Section 874.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5350 Suction antichoke device. (a...

  12. 21 CFR 874.5350 - Suction antichoke device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Suction antichoke device. 874.5350 Section 874.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5350 Suction antichoke device. (a...

  13. 21 CFR 874.5370 - Tongs antichoke device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tongs antichoke device. 874.5370 Section 874.5370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5370 Tongs antichoke device. (a...

  14. 21 CFR 874.5350 - Suction antichoke device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Suction antichoke device. 874.5350 Section 874.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5350 Suction antichoke device. (a...

  15. 21 CFR 874.5350 - Suction antichoke device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Suction antichoke device. 874.5350 Section 874.5350 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5350 Suction antichoke device. (a...

  16. 21 CFR 874.5370 - Tongs antichoke device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tongs antichoke device. 874.5370 Section 874.5370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5370 Tongs antichoke device. (a...

  17. 21 CFR 874.5370 - Tongs antichoke device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tongs antichoke device. 874.5370 Section 874.5370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5370 Tongs antichoke device. (a...

  18. 21 CFR 874.5370 - Tongs antichoke device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tongs antichoke device. 874.5370 Section 874.5370 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5370 Tongs antichoke device. (a...

  19. 21 CFR 864.6100 - Bleeding time device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Bleeding time device. 864.6100 Section 864.6100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6100 Bleeding time device...

  20. 21 CFR 864.6100 - Bleeding time device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bleeding time device. 864.6100 Section 864.6100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6100 Bleeding time device...

  1. 21 CFR 864.6100 - Bleeding time device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Bleeding time device. 864.6100 Section 864.6100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6100 Bleeding time device...

  2. 21 CFR 864.6100 - Bleeding time device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Bleeding time device. 864.6100 Section 864.6100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6100 Bleeding time device...

  3. 21 CFR 864.6100 - Bleeding time device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Bleeding time device. 864.6100 Section 864.6100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Manual Hematology Devices § 864.6100 Bleeding time device...

  4. 21 CFR 878.4930 - Suture retention device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

  5. 21 CFR 878.4930 - Suture retention device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

  6. 21 CFR 878.4930 - Suture retention device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

  7. 21 CFR 878.4930 - Suture retention device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

  8. 21 CFR 878.4930 - Suture retention device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

  9. Methods and devices for fabricating and assembling printable semiconductor elements

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nuzzo, Ralph G.; Rogers, John A.; Menard, Etienne

    The invention provides methods and devices for fabricating printable semiconductor elements and assembling printable semiconductor elements onto substrate surfaces. Methods, devices and device components of the present invention are capable of generating a wide range of flexible electronic and optoelectronic devices and arrays of devices on substrates comprising polymeric materials. The present invention also provides stretchable semiconductor structures and stretchable electronic devices capable of good performance in stretched configurations.

  10. Methods and devices for fabricating and assembling printable semiconductor elements

    DOEpatents

    Nuzzo, Ralph G; Rogers, John A; Menard, Etienne; Lee, Keon Jae; Khang, Dahl-Young; Sun, Yugang; Meitl, Matthew; Zhu, Zhengtao

    2014-03-04

    The invention provides methods and devices for fabricating printable semiconductor elements and assembling printable semiconductor elements onto substrate surfaces. Methods, devices and device components of the present invention are capable of generating a wide range of flexible electronic and optoelectronic devices and arrays of devices on substrates comprising polymeric materials. The present invention also provides stretchable semiconductor structures and stretchable electronic devices capable of good performance in stretched configurations.

  11. Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

    PubMed

    2015-11-20

    The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  12. The Importance of State and Context in Safe Interoperable Medical Systems

    PubMed Central

    Jaffe, Michael B.; Robkin, Michael; Rausch, Tracy; Arney, David; Goldman, Julian M.

    2016-01-01

    This paper describes why “device state” and “patient context” information are necessary components of device models for safe interoperability. This paper includes a discussion of the importance of describing the roles of devices with respect to interactions (including human user workflows involving devices, and device to device communication) within a system, particularly those intended for use at the point-of-care, and how this role information is communicated. In addition, it describes the importance of clinical scenarios in creating device models for interoperable devices. PMID:27730013

  13. Policy-based secure communication with automatic key management for industrial control and automation systems

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Chernoguzov, Alexander; Markham, Thomas R.; Haridas, Harshal S.

    A method includes generating at least one access vector associated with a specified device in an industrial process control and automation system. The specified device has one of multiple device roles. The at least one access vector is generated based on one or more communication policies defining communications between one or more pairs of devices roles in the industrial process control and automation system, where each pair of device roles includes the device role of the specified device. The method also includes providing the at least one access vector to at least one of the specified device and one ormore » more other devices in the industrial process control and automation system in order to control communications to or from the specified device.« less

  14. Progress and Prospects in Stretchable Electroluminescent Devices

    NASA Astrophysics Data System (ADS)

    Wang, Jiangxin; Lee, Pooi See

    2017-03-01

    Stretchable electroluminescent (EL) devices are a new form of mechanically deformable electronics that are gaining increasing interests and believed to be one of the essential technologies for next generation lighting and display applications. Apart from the simple bending capability in flexible EL devices, the stretchable EL devices are required to withstand larger mechanical deformations and accommodate stretching strain beyond 10%. The excellent mechanical conformability in these devices enables their applications in rigorous mechanical conditions such as flexing, twisting, stretching, and folding.The stretchable EL devices can be conformably wrapped onto arbitrary curvilinear surface and respond seamlessly to the external or internal forces, leading to unprecedented applications that cannot be addressed with conventional technologies. For example, they are in demand for wide applications in biomedical-related devices or sensors and soft interactive display systems, including activating devices for photosensitive drug, imaging apparatus for internal tissues, electronic skins, interactive input and output devices, robotics, and volumetric displays. With increasingly stringent demand on the mechanical requirements, the fabrication of stretchable EL device is encountering many challenges that are difficult to resolve. In this review, recent progresses in the stretchable EL devices are covered with a focus on the approaches that are adopted to tackle materials and process challenges in stretchable EL devices and delineate the strategies in stretchable electronics. We first introduce the emission mechanisms that have been successfully demonstrated on stretchable EL devices. Limitations and advantages of the different mechanisms for stretchable EL devices are also discussed. Representative reports are reviewed based on different structural and material strategies. Unprecedented applications that have been enabled by the stretchable EL devices are reviewed. Finally, we summarize with our perspectives on the approaches for the stretchable EL devices and our proposals on the future development in these devices.

  15. Multiple constraints compromise decision-making about implantable medical devices for individual patients: qualitative interviews with physicians.

    PubMed

    Gagliardi, Anna R; Ducey, Ariel; Lehoux, Pascale; Turgeon, Thomas; Kolbunik, Jeremy; Ross, Sue; Trbovich, Patricia; Easty, Anthony; Bell, Chaim; Urbach, David R

    2017-12-22

    Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options. A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team. Twenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications. This study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients.

  16. [Comparative study of device labeling regulation in U.S.A. and China].

    PubMed

    Li, Fei; Wei, Jing; Ma, Yanbin; Li, Zhu

    2010-09-01

    To provide references for the evolvement of medical devices labeling and manual administration in China, By content analysis, 10 juristic documents relevant to device labeling and manual were collected from FDA website, compared to which, the federal regulation was mainly analyzed. There are five main differences of device labeling regulation between U.S.A. and China: juristic system, administrative scope, administrative target, characteristics and practice, A set of comprehensive juristic system for device labeling has been established by FDA. from which China should draw experience, to administrate the prescription devices and the over-the-counter devices in classification, and set up device labeling guidance, thus guarantee the safety and efficacy of device.

  17. Surface Acoustic Wave Monitor for Deposition and Analysis of Ultra-Thin Films

    NASA Technical Reports Server (NTRS)

    Hines, Jacqueline H. (Inventor)

    2015-01-01

    A surface acoustic wave (SAW) based thin film deposition monitor device and system for monitoring the deposition of ultra-thin films and nanomaterials and the analysis thereof is characterized by acoustic wave device embodiments that include differential delay line device designs, and which can optionally have integral reference devices fabricated on the same substrate as the sensing device, or on a separate device in thermal contact with the film monitoring/analysis device, in order to provide inherently temperature compensated measurements. These deposition monitor and analysis devices can include inherent temperature compensation, higher sensitivity to surface interactions than quartz crystal microbalance (QCM) devices, and the ability to operate at extreme temperatures.

  18. 21 CFR 872.1745 - Laser fluorescence caries detection device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1745 Laser fluorescence caries... fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as...

  19. 21 CFR 872.1745 - Laser fluorescence caries detection device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.1745 Laser fluorescence caries... fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as...

  20. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  1. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

  2. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  3. 76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ...] Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This... INFORMATION: In the Federal Register of February 7, 2011, FDA announced that a meeting of the Neurological...

  4. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General... also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus...

  5. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General..., introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper. FDA intends to...

  6. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  7. 76 FR 69034 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...

  8. 75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

  9. 76 FR 54156 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-31

    ... traffic control device design, location, or operation that have made some existing devices in the field...-2010-0159] RIN 2125-AF43 National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Revision AGENCY: Federal Highway Administration (FHWA...

  10. 21 CFR 868.5115 - Device to relieve acute upper airway obstruction.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device to relieve acute upper airway obstruction. 868.5115 Section 868.5115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5115 Device to...

  11. 21 CFR 868.5115 - Device to relieve acute upper airway obstruction.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Device to relieve acute upper airway obstruction. 868.5115 Section 868.5115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5115 Device to...

  12. 21 CFR 868.5115 - Device to relieve acute upper airway obstruction.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device to relieve acute upper airway obstruction. 868.5115 Section 868.5115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5115 Device to...

  13. 14 CFR 23.373 - Speed control devices.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Speed control devices. 23.373 Section 23....373 Speed control devices. If speed control devices (such as spoilers and drag flaps) are incorporated....441 and 23.443, with the device extended at speeds up to the placard device extended speed; and (b) If...

  14. 14 CFR 23.373 - Speed control devices.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Speed control devices. 23.373 Section 23....373 Speed control devices. If speed control devices (such as spoilers and drag flaps) are incorporated....441 and 23.443, with the device extended at speeds up to the placard device extended speed; and (b) If...

  15. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

  16. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  17. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  18. 21 CFR 830.300 - Devices subject to device identification data submission requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Devices subject to device identification data submission requirements. 830.300 Section 830.300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Identification Database § 830.300 Devices subject to device identification data submission requirements. (a) In...

  19. 21 CFR 880.6785 - Manual patient transfer device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Miscellaneous Devices § 880.6785 Manual patient transfer device. (a) Identification. A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual patient transfer device. 880.6785 Section...

  20. The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

    PubMed

    Weininger, Sandy; Jaffe, Michael B; Goldman, Julian M

    2017-01-01

    Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

  1. The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems

    PubMed Central

    Weininger, Sandy; Jaffe, Michael B.; Goldman, Julian M

    2016-01-01

    Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account this systems perspective. In this article we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups; some which focus on safety and effectiveness, and others that focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development. PMID:27584685

  2. Regulatory science based approach in development of novel medical devices.

    PubMed

    Sakuma, Ichiro

    2015-08-01

    For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.

  3. Implantation reduces the negative effects of bio-logging devices on birds.

    PubMed

    White, Craig R; Cassey, Phillip; Schimpf, Natalie G; Halsey, Lewis G; Green, Jonathan A; Portugal, Steven J

    2013-02-15

    Animal-borne logging or telemetry devices are widely used for measurements of physiological and movement data from free-living animals. For such measurements to be relevant, however, it is essential that the devices themselves do not affect the data of interest. A recent meta-analysis reported an overall negative effect of these devices on the birds that bear them, i.e. on nesting productivity, clutch size, nest initiation date, offspring quality, body condition, flying ability, foraging behaviours, energy expenditure and survival rate. Method of attachment (harness, collar, glue, anchor, implant, breast-mounted or tailmount) had no influence on the strength of these effects but anchored and implanted transmitters had the highest reported rates of device-induced mortality. Furthermore, external devices, but not internal devices, caused an increase in 'device-induced behaviour' (comfort behaviours such as preening, fluffing and stretching, and unrest activities including unquantifiable 'active' behaviours). These findings suggest that, with the exception of device-induced behaviour, external attachment is preferable to implantation. In the present study we undertake a meta-analysis of 183 estimates of device impact from 39 studies of 36 species of bird designed to explicitly compare the effects of externally attached and surgically implanted devices on a range of traits, including condition, energy expenditure and reproduction. In contrast to a previous study, we demonstrate that externally attached devices have a consistent detrimental effect (i.e. negative influences on body condition, reproduction, metabolism and survival), whereas implanted devices have no consistent effect. We also show that the magnitude of the negative effect of externally attached devices decreases with time. We therefore conclude that device implantation is preferable to external attachment, providing that the risk of mortality associated with the anaesthesia and surgery required for implantation can be mitigated. We recommend that studies employing external devices use devices that can be borne for long periods, and, wherever possible, deploy devices in advance of the time period of interest.

  4. Adolescents' Use of Basic, Intermediate, and Advanced Device Types for Vaping.

    PubMed

    Pepper, Jessica K; MacMonegle, Anna J; Nonnemaker, James M

    2017-12-23

    Advanced models of electronic vaping products (EVPs) likely pose a greater risk to adolescent health than basic or intermediate models because advanced models deliver nicotine more effectively and heat e-liquid to higher temperatures, producing more harmful chemical emissions. However, little is known about adolescents' risk factors for using different device types. We used social media to recruit an online sample of 1,508 U.S. adolescents aged 15-17 who reported past 30-day use of e-cigarettes. We assessed tobacco use, beliefs and knowledge about EVPs, and EVP use behavior, including the device type participants use most frequently. We used multinomial logistic regression to examine differences between adolescents who usually use intermediate versus basic and advanced versus basic devices. Most respondents usually used modifiable advanced devices (56.8%) rather than basic "cigalike" (14.5%) or pen-style intermediate (28.7%) devices. Use of multiple device types was common, particularly among those who primarily used basic devices. Younger age and less frequent vaping were associated with mainly using basic devices. Adolescents who were older, male, personally bought their main device, and had ever mixed e-liquids were at elevated risk for usually using advanced devices. Adolescents who primarily use basic devices may be newer users who are experimenting with multiple devices. Future research should examine which adolescents are most likely to transition to advanced devices in order to develop targeted interventions. Regulators should consider strategies to reduce access to all types of EVPs, such as better enforcement of the current ban on sales to minors. This research addresses two gaps in research on adolescent electronic vaping product use: (1) characterizing use of advanced devices as distinct from intermediate devices rather than grouping them together and (2) examining factors associated with use of specific device types. This study suggests that there are distinct profiles of adolescents who use primarily basic, intermediate, or advanced devices. Adolescents who most often use basic devices may be new users experimenting with vaping, whereas adolescents who most often use advanced devices appear to be buying devices for themselves and engaging in risky behaviors such as mixing their own e-liquid. © The Author(s) 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Fabrication of a microfluidic device for the compartmentalization of neuron soma and axons.

    PubMed

    Harris, Joseph; Lee, Hyuna; Vahidi, Behrad; Tu, Christina; Cribbs, David; Jeon, Noo Li; Cotman, Carl

    2007-01-01

    In this video, we demonstrate the technique of soft lithography with polydimethyl siloxane (PDMS) which we use to fabricate a microfluidic device for culturing neurons. Previously, a silicon wafer was patterned with the design for the neuron microfluidic device using SU-8 and photolithography to create a master mold, or what we simply refer to as a "master". Next, we pour the silicon polymer PDMS on top of the master which is then cured by heating the PDMS to 80 degrees C for 1 hour. The PDMS forms a negative mold of the device. The PDMS is then carefully cut and lifted away from the master. Holes are punched where the reservoirs will be and the excess PDMS trimmed away from the device. Nitrogen is used to blow away any excess debris from the device. At this point the devices are now ready for use and can either bonded to corning No. 1 cover glass with a plasma sterilizer/cleaner or can be reversibly bound to the cover glass by simply placing the device on top of the cover glass. The reversible bonding of the device to glass is covered in a separate video and requires first that the device be sterilized either with 70% ethanol or by autoclaving. Plasma treating sterilizes the devices so no further treatment is necessary. It is, however, important, when plasma-treating the devices, to add liquid to the devices within 10 minutes of the plasma treatment while the surfaces are still hydrophilic. Waiting longer than 10 minutes to add liquid to the device makes it difficult for the liquid to enter the device. The neuron devices are typically plasma-bound to cover glass and 0.5 mg/ml poly-L-lysine (PLL) in pH 8.5 borate buffer is immediately added to the device. After a minimum of 3 hours incubating with PLL, the devices are washed with dH2O water a minimum of 3 times with at least 15 minutes between each wash. Next, the water is removed and fresh media is added to the device. At this point the device is ready for use. It is important to remember at this point to never remove all the media from the device. Always leave media in the main channel.

  6. [Industry regulation and its relationship to the rapid marketing of medical devices].

    PubMed

    Matsuoka, Atsuko

    2012-01-01

    In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

  7. An Integrated Device View on Photo-Electrochemical Solar-Hydrogen Generation.

    PubMed

    Modestino, Miguel A; Haussener, Sophia

    2015-01-01

    Devices that directly capture and store solar energy have the potential to significantly increase the share of energy from intermittent renewable sources. Photo-electrochemical solar-hydrogen generators could become an important contributor, as these devices can convert solar energy into fuels that can be used throughout all sectors of energy. Rather than focusing on scientific achievement on the component level, this article reviews aspects of overall component integration in photo-electrochemical water-splitting devices that ultimately can lead to deployable devices. Throughout the article, three generalized categories of devices are considered with different levels of integration and spanning the range of complete integration by one-material photo-electrochemical approaches to complete decoupling by photovoltaics and electrolyzer devices. By using this generalized framework, we describe the physical aspects, device requirements, and practical implications involved with developing practical photo-electrochemical water-splitting devices. Aspects reviewed include macroscopic coupled multiphysics device models, physical device demonstrations, and economic and life cycle assessments, providing the grounds to draw conclusions on the overall technological outlook.

  8. Development of reversible vas deferens occlusive device: IV. Rigid prosthetic devices.

    PubMed

    Drueschke, E E; Zaneveld, L J; Burns, M; Rodzen, R; Wingfield, J R; Maness, J H

    1975-01-01

    Different types of rigid, reversible, vas deferens occlusive devices were developed and evaluated in 14 unilaterally vasectomized dogs. All prosthetic devices had molded silicone rubber bodies, and rigid inflow and outflow tubes. Various techniques for the removal of the vas luminal epithelium, and for the preparation of porous ceramic and etched stainless steel surfaces to encourage tissue ingrowth into the prosthetic device end tubues were attempted. The devices differed in their methods of achieving occlusion. One device used a "rotary stem valve" which had a C-section rotating mechanism; the others used the "shuttle stem valve" which possessed an occlusive element that moved transverse to the axis of flow in the device, thus occluding the device when the stem was depressed. The rotarystem valve was implanted by means of a longitudinal incision. The remaining 13 shuttle stem devices were placed in the vas using either a longitudinal or a transverse implantation. Inno case was sperm transport through the prosthetic devices obtained for more than a few ejaculations.

  9. [Status of diagnosis and treatment devices of acupuncture based on SooPAT and bibliometrics in China].

    PubMed

    Bai, Lin; Ren, Yulan; Guo, Taipin; Chen, Lin; Zhou, Yumei; Feng, Shuwei; Li, Ji; Liang, Fanrong

    2016-11-12

    To perform a bibliometrics analysis on patent literature regarding diagnosis and treatment devices of acupuncture in China, aiming to provide references for the development of diagnosis and treatment devices of acupuncture. Based on SooPAT, a patent database, the patent literature regarding diagnosis and treatment devices of acupuncture in China was collected. With bibliometrics methods, the annual distribution of type, quantity, classification and content of diagnosis and treatment devices of acupuncture were analyzed. The number of acupuncture diagnosis and treatment devices reached its peak in 2012 and 2013 in China. The A61N in patent and utility model patent were the most, which were mainly related to electrotherapy, magnetic therapy, radioactive therapy and ultrasound therapy, etc. The main content was acupuncture treatment devices and meridian treatment devices. The 24-01 in design patent was the most, involving fixation devices used by doctors, hospitals and laboratories, etc. Currently the majority of diagnosis and treatment devices of acupuncture is therapeutic apparatus, while the acupuncture diagnosis devices are needed.

  10. Technology assessment of medical devices at the Center for Devices and Radiological Health.

    PubMed

    Kessler, L; Richter, K

    1998-09-25

    We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.

  11. Power spectrum analysis for defect screening in integrated circuit devices

    DOEpatents

    Tangyunyong, Paiboon; Cole Jr., Edward I.; Stein, David J.

    2011-12-01

    A device sample is screened for defects using its power spectrum in response to a dynamic stimulus. The device sample receives a time-varying electrical signal. The power spectrum of the device sample is measured at one of the pins of the device sample. A defect in the device sample can be identified based on results of comparing the power spectrum with one or more power spectra of the device that have a known defect status.

  12. Cooling of superconducting devices by liquid storage and refrigeration unit

    DOEpatents

    Laskaris, Evangelos Trifon; Urbahn, John Arthur; Steinbach, Albert Eugene

    2013-08-20

    A system is disclosed for cooling superconducting devices. The system includes a cryogen cooling system configured to be coupled to the superconducting device and to supply cryogen to the device. The system also includes a cryogen storage system configured to supply cryogen to the device. The system further includes flow control valving configured to selectively isolate the cryogen cooling system from the device, thereby directing a flow of cryogen to the device from the cryogen storage system.

  13. 21 CFR 806.20 - Records of corrections and removals not required to be reported.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND... known, and the intended use of the device. (2) The model, catalog, or code number of the device and the...) Each device manufacturer or importer who initiates a correction or removal of a device that is not...

  14. 21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING User... device; (10) Event problem codes—patient code and device code (refer to the “MEDWATCH Medical Device... device was involved, nature of the problem, patient followup or required treatment, and any environmental...

  15. 21 CFR 803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING User... device; (10) Event problem codes—patient code and device code (refer to the “MEDWATCH Medical Device... device was involved, nature of the problem, patient followup or required treatment, and any environmental...

  16. 21 CFR 806.20 - Records of corrections and removals not required to be reported.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND... known, and the intended use of the device. (2) The model, catalog, or code number of the device and the...) Each device manufacturer or importer who initiates a correction or removal of a device that is not...

  17. Pipe inspection and repair system

    NASA Technical Reports Server (NTRS)

    Schempf, Hagen (Inventor); Mutschler, Edward (Inventor); Chemel, Brian (Inventor); Boehmke, Scott (Inventor); Crowley, William (Inventor)

    2004-01-01

    A multi-module pipe inspection and repair device. The device includes a base module, a camera module, a sensor module, an MFL module, a brush module, a patch set/test module, and a marker module. Each of the modules may be interconnected to construct one of an inspection device, a preparation device, a marking device, and a repair device.

  18. An UV photochromic memory effect in proton-based WO3 electrochromic devices

    NASA Astrophysics Data System (ADS)

    Zhang, Yong; Lee, S.-H.; Mascarenhas, A.; Deb, S. K.

    2008-11-01

    We report an UV photochromic memory effect on a standard proton-based WO3 electrochromic device. It exhibits two memory states, associated with the colored and bleached states of the device, respectively. Such an effect can be used to enhance device performance (increasing the dynamic range), re-energize commercial electrochromic devices, and develop memory devices.

  19. 78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... information that will have been reviewed by the applicant during the course of its development of the device..., infants, children, adolescents) that suffer from the disease or condition that the device is intended to.... FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirement for Submission...

  20. Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. Final order.

    PubMed

    2017-12-20

    The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  1. Method for triggering an action

    DOEpatents

    Hall, David R.; Bartholomew, David B.; Johnson, Monte L.; Moon, Justin; Koehler, Roger O.

    2006-10-17

    A method for triggering an action of at least one downhole device on a downhole network integrated into a downhole tool string synchronized to an event comprises determining latency, sending a latency adjusted signal, and performing the action. The latency is determined between a control device and the at least one downhole device. The latency adjusted signal for triggering an action is sent to the downhole device. The action is performed downhole synchronized to the event. A preferred method for determining latency comprises the steps: a control device sends a first signal to the downhole device; after receiving the signal, the downhole device sends a response signal to the control device; and the control device analyzes the time from sending the signal to receiving the response signal.

  2. Radiofrequency ablation for hepatocellular carcinoma: a prospective comparison of four radiofrequency devices.

    PubMed

    Lin, Shi-Ming; Lin, Chen-Chun; Chen, Wei-Ting; Chen, Yi-Chen; Hsu, Chao-Wei

    2007-09-01

    To compare the effectiveness of ablation techniques for hepatocellular carcinoma (HCC) with the use of four radiofrequency (RF) devices. One hundred patients with 133 HCC lesions no larger than 4 cm were treated with one of four RF devices: RF 2000 (maximum power, 100 W) and RF 3000 generators (maximum power, 200 W) with LeVeen expandable electrodes with a maximum dimension of 3.5 cm or 4 cm, internally cooled single electrode with a thermal dimension of 3 cm, and a RITA RF generator with expandable electrodes with a maximum dimension of 5 cm. Numbers of RF sessions needed per HCC to achieve complete necrosis were 1.4 +/- 0.5 with the RF 2000 device and greater than 1.1 +/- 0.3 with the other three devices (P < .05). The RF 2000 device required a more interactive algorithm than the RF 3000 device. Session times per patient were 31.7 minutes +/- 13.2 in the RF 2000 group and longer than 16.6 minutes +/- 7.5 in the RF 3000 group, 28.3 minutes +/- 12 in the RITA device group, and 27.1 minutes +/- 12 with the internally cooled electrode device (P < .005 for RF 2000 vs other devices and for RF 3000 vs RITA or internally cooled electrode device). Complete necrosis and local tumor progression rates at 2 years in the RF 2000, RF 3000, RITA, and internally cooled electrode device groups were 91.1%, 97.1%, 96.7%, and 96.8% and 12%, 8%, 8.2%, and 8.3%, respectively (P = .37). Ablation with the RF 3000 device required a shorter time than the other three devices and required a less interactive algorithm than the RF 2000 device. However, complete necrosis and local tumor progression rates were similar among devices.

  3. FDA's perspectives on cardiovascular devices.

    PubMed

    Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

    2009-06-01

    The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

  4. Materials for electrochemical device safety

    DOEpatents

    Vissers, Daniel R.; Amine, Khalil; Thackeray, Michael M.; Kahaian, Arthur J.; Johnson, Christopher S.

    2015-04-07

    An electrochemical device includes a thermally-triggered intumescent material or a gas-triggered intumescent material. Such devices prevent or minimize short circuits in a device that could lead to thermal run-away. Such devices may include batteries or supercapacitors.

  5. Illusion thermal device based on material with constant anisotropic thermal conductivity for location camouflage

    NASA Astrophysics Data System (ADS)

    Hou, Quanwen; Zhao, Xiaopeng; Meng, Tong; Liu, Cunliang

    2016-09-01

    Thermal metamaterials and devices based on transformation thermodynamics often require materials with anisotropic and inhomogeneous thermal conductivities. In this study, still based on the concept of transformation thermodynamics, we designed a planar illusion thermal device, which can delocalize a heat source in the device such that the temperature profile outside the device appears to be produced by a virtual source at another position. This device can be constructed by only one kind of material with constant anisotropic thermal conductivity. The condition which should be satisfied by the device is provided, and the required anisotropic thermal conductivity is then deduced theoretically. This study may be useful for the designs of metamaterials or devices since materials with constant anisotropic parameters have great facility in fabrication. A prototype device has been fabricated based on a composite composed by two naturally occurring materials. The experimental results validate the effectiveness of the device.

  6. Flexible devices: from materials, architectures to applications

    NASA Astrophysics Data System (ADS)

    Zou, Mingzhi; Ma, Yue; Yuan, Xin; Hu, Yi; Liu, Jie; Jin, Zhong

    2018-01-01

    Flexible devices, such as flexible electronic devices and flexible energy storage devices, have attracted a significant amount of attention in recent years for their potential applications in modern human lives. The development of flexible devices is moving forward rapidly, as the innovation of methods and manufacturing processes has greatly encouraged the research of flexible devices. This review focuses on advanced materials, architecture designs and abundant applications of flexible devices, and discusses the problems and challenges in current situations of flexible devices. We summarize the discovery of novel materials and the design of new architectures for improving the performance of flexible devices. Finally, we introduce the applications of flexible devices as key components in real life. Project supported by the National Key R&D Program of China (Nos. 2017YFA0208200, 2016YFB0700600, 2015CB659300), the National Natural Science Foundation of China (Nos. 21403105, 21573108), and the Fundamental Research Funds for the Central Universities (No. 020514380107).

  7. The FDA's role in medical device clinical studies of human subjects

    NASA Astrophysics Data System (ADS)

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

  8. Method and system for reducing device performance degradation of organic devices

    DOEpatents

    Teague, Lucile C.

    2014-09-02

    Methods and systems for reducing the deleterious effects of gate bias stress on the drain current of an organic device, such as an organic thin film transistor, are provided. In a particular aspect, the organic layer of an organic device is illuminated with light having characteristics selected to reduce the gate bias voltage effects on the drain current of the organic device. For instance, the wavelength and intensity of the light are selected to provide a desired recovery of drain current of the organic device. If the characteristics of the light are appropriately matched to the organic device, recovery of the deleterious effects caused by gate bias voltage stress effects on the drain current of the organic device can be achieved. In a particular aspect, the organic device is selectively illuminated with light to operate the organic device in multiple modes of operation.

  9. Non- contacting capacitive diagnostic device

    DOEpatents

    Ellison, Timothy

    2005-07-12

    A non-contacting capacitive diagnostic device includes a pulsed light source for producing an electric field in a semiconductor or photovoltaic device or material to be evaluated and a circuit responsive to the electric field. The circuit is not in physical contact with the device or material being evaluated and produces an electrical signal characteristic of the electric field produced in the device or material. The diagnostic device permits quality control and evaluation of semiconductor or photovoltaic device properties in continuous manufacturing processes.

  10. Method for integrating microelectromechanical devices with electronic circuitry

    DOEpatents

    Montague, Stephen; Smith, James H.; Sniegowski, Jeffry J.; McWhorter, Paul J.

    1998-01-01

    A method for integrating one or more microelectromechanical (MEM) devices with electronic circuitry. The method comprises the steps of forming each MEM device within a cavity below a device surface of the substrate; encapsulating the MEM device prior to forming electronic circuitry on the substrate; and releasing the MEM device for operation after fabrication of the electronic circuitry. Planarization of the encapsulated MEM device prior to formation of the electronic circuitry allows the use of standard processing steps for fabrication of the electronic circuitry.

  11. Update on Tissue Tightening

    PubMed Central

    2010-01-01

    A variety of medical devices are described under the heading of tissue tightening devices. This article reviews the tissue tightening devices currently available in the United States and some that may receive clearance in the upcoming year. These include the various radiofrequency devices as well as the pulsed light devices that achieve similar end results. The one noticeable factor seen with this group of devices is the paucity of large, clinical, controlled trials that appear in the medical literature for this group of medical devices as a whole. PMID:20725568

  12. Perceptions of healthcare professionals' support, shock anxiety and device acceptance among implantable cardioverter defibrillator recipients.

    PubMed

    Morken, Ingvild M; Norekvål, Tone M; Bru, Edvin; Larsen, Alf I; Karlsen, Bjørg

    2014-09-01

    To investigate the extent to which perceived support from healthcare professionals and shock anxiety is related to device acceptance among implantable cardioverter defibrillator recipients. Device acceptance can be influenced by several factors, one of which is shock anxiety associated with poor device acceptance. Reduced shock anxiety, as well as increased device acceptance, has been reported after psycho-educational programmes. As healthcare professionals appear to play a significant role in providing support and education during regular follow-up visits, they may constitute an important social support system that could be another factor influencing device acceptance. However, little is known about the relationship between perceived support from healthcare professionals and device acceptance among recipients. A cross-sectional survey design. A sample comprising implantable cardioverter defibrillator recipients completed questionnaires assessing perceived support from healthcare professionals, shock anxiety and device acceptance. Demographic and clinical data were collected by self-report and from medical records in September-October 2010. The descriptive results indicated that approximately 85% of the recipients experienced high device acceptance. Regression analysis demonstrated that constructive support from healthcare professionals was positively associated with device acceptance and moderated the negative relationship between shock anxiety and device acceptance. Non-constructive support and shock anxiety had a negative statistical association with device acceptance. Healthcare professionals may represent a valuable constructive support system that can enhance device acceptance among implantable cardioverter defibrillator recipients, partly by preventing shock anxiety from leading to poor device acceptance. Non-constructive communication on the part of healthcare professionals could hinder device acceptance. © 2014 John Wiley & Sons Ltd.

  13. Implantable biomedical devices on bioresorbable substrates

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rogers, John A.; Kim, Dae-Hyeong; Omenetto, Fiorenzo

    Provided herein are implantable biomedical devices and methods of administering implantable biomedical devices, making implantable biomedical devices, and using implantable biomedical devices to actuate a target tissue or sense a parameter associated with the target tissue in a biological environment.

  14. 16 CFR 1507.9 - Toy smoke devices and flitter devices.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.9 Toy smoke devices and flitter devices. (a) Toy smoke... shall not be of such color and configuration so as to be confused with banned fireworks such as M-80...

  15. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nuzzo, Ralph G.; Rogers, John A.; Menard, Etienne

    The invention provides methods and devices for fabricating printable semiconductor elements and assembling printable semiconductor elements onto substrate surfaces. Methods, devices and device components of the present invention are capable of generating a wide range of flexible electronic and optoelectronic devices and arrays of devices on substrates comprising polymeric materials. The present invention also provides stretchable semiconductor structures and stretchable electronic devices capable of good performance in stretched configurations.

  16. Wireless event-recording device with identification codes

    NASA Technical Reports Server (NTRS)

    Watters, David G. (Inventor); Huestis, David L. (Inventor); Bahr, Alfred J. (Inventor)

    2004-01-01

    A wireless recording device can be interrogated to determine its identity and its state. The state indicates whether a particular physical or chemical event has taken place. In effect, the physical or chemical event is recorded by the device. The identity of the device allows it to be distinguished from a number of similar devices. Thus the sensor device may be used in an array of devices that can be probed by a wireless interrogation unit. The device tells the interrogator who it is and what state it is in. The interrogator can thus easily identify particular items in an array that have reached a particular condition.

  17. Energy conversion device with support member having pore channels

    DOEpatents

    Routkevitch, Dmitri [Longmont, CO; Wind, Rikard A [Johnstown, CO

    2014-01-07

    Energy devices such as energy conversion devices and energy storage devices and methods for the manufacture of such devices. The devices include a support member having an array of pore channels having a small average pore channel diameter and having a pore channel length. Material layers that may include energy conversion materials and conductive materials are coaxially disposed within the pore channels to form material rods having a relatively small cross-section and a relatively long length. By varying the structure of the materials in the pore channels, various energy devices can be fabricated, such as photovoltaic (PV) devices, radiation detectors, capacitors, batteries and the like.

  18. Micro devices using shape memory polymer patches for mated connections

    DOEpatents

    Lee, Abraham P.; Fitch, Joseph P.

    2000-01-01

    A method and micro device for repositioning or retrieving miniature devices located in inaccessible areas, such as medical devices (e.g., stents, embolic coils, etc.) located in a blood vessel. The micro repositioning or retrieving device and method uses shape memory polymer (SMP) patches formed into mating geometries (e.g., a hoop and a hook) for re-attachment of the deposited medical device to a catheter or guidewire. For example, SMP or other material hoops are formed on the medical device to be deposited in a blood vessel, and SMP hooks are formed on the micro device attached to a guidewire, whereby the hooks on the micro device attach to the hoops on the medical device, or vice versa, enabling deposition, movement, re-deposit, or retrieval of the medical device. By changing the temperature of the SMP hooks, the hooks can be attached to or released from the hoops located on the medical device. An exemplary method for forming the hooks and hoops involves depositing a sacrificial thin film on a substrate, patterning and processing the thin film to form openings therethrough, depositing or bonding SMP materials in the openings so as to be attached to the substrate, and removing the sacrificial thin film.

  19. A literature review of the effects of computer input device design on biomechanical loading and musculoskeletal outcomes during computer work.

    PubMed

    Bruno Garza, J L; Young, J G

    2015-01-01

    Extended use of conventional computer input devices is associated with negative musculoskeletal outcomes. While many alternative designs have been proposed, it is unclear whether these devices reduce biomechanical loading and musculoskeletal outcomes. To review studies describing and evaluating the biomechanical loading and musculoskeletal outcomes associated with conventional and alternative input devices. Included studies evaluated biomechanical loading and/or musculoskeletal outcomes of users' distal or proximal upper extremity regions associated with the operation of alternative input devices (pointing devices, mice, other devices) that could be used in a desktop personal computing environment during typical office work. Some alternative pointing device designs (e.g. rollerbar) were consistently associated with decreased biomechanical loading while other designs had inconsistent results across studies. Most alternative keyboards evaluated in the literature reduce biomechanical loading and musculoskeletal outcomes. Studies of other input devices (e.g. touchscreen and gestural controls) were rare, however, those reported to date indicate that these devices are currently unsuitable as replacements for traditional devices. Alternative input devices that reduce biomechanical loading may make better choices for preventing or alleviating musculoskeletal outcomes during computer use, however, it is unclear whether many existing designs are effective.

  20. The current situation and development of medical device testing institutes in China.

    PubMed

    Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu

    2017-04-01

    This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.

  1. Design of a SIP device cooperation system on OSGi service platforms

    NASA Astrophysics Data System (ADS)

    Takayama, Youji; Koita, Takahiro; Sato, Kenya

    2007-12-01

    Home networks feature such various technologies as protocols, specifications, and middleware, including HTTP, UPnP, and Jini. A service platform is required to handle such technologies to enable them to cooperate with different devices. The OSGi service platform, which meets the requirements based on service-oriented architecture, is designed and standardized by OSGi Alliance and consists of two parts: one OSGi Framework and bundles. On the OSGi service platform, APIs are defined as services that can handle these technologies and are implemented in the bundle. By using the OSGi Framework with bundles, various technologies can cooperate with each other. On the other hand, in IP networks, Session Initiation Protocol (SIP) is often used in device cooperation services to resolve an IP address, control a session between two or more devices, and easily exchange the statuses of devices. However, since many existing devices do not correspond to SIP, it cannot be used for device cooperation services. A device that does not correspond to SIP is called an unSIP device. This paper proposes and implements a prototype system that enables unSIP devices to correspond to SIP. For unSIP devices, the proposed system provides device cooperation services with SIP.

  2. Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

    PubMed

    Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

    2017-12-01

    The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%. Published by Elsevier Inc.

  3. Simulating ideal assistive devices to reduce the metabolic cost of walking with heavy loads.

    PubMed

    Dembia, Christopher L; Silder, Amy; Uchida, Thomas K; Hicks, Jennifer L; Delp, Scott L

    2017-01-01

    Wearable robotic devices can restore and enhance mobility. There is growing interest in designing devices that reduce the metabolic cost of walking; however, designers lack guidelines for which joints to assist and when to provide the assistance. To help address this problem, we used musculoskeletal simulation to predict how hypothetical devices affect muscle activity and metabolic cost when walking with heavy loads. We explored 7 massless devices, each providing unrestricted torque at one degree of freedom in one direction (hip abduction, hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion, or ankle dorsiflexion). We used the Computed Muscle Control algorithm in OpenSim to find device torque profiles that minimized the sum of squared muscle activations while tracking measured kinematics of loaded walking without assistance. We then examined the metabolic savings provided by each device, the corresponding device torque profiles, and the resulting changes in muscle activity. We found that the hip flexion, knee flexion, and hip abduction devices provided greater metabolic savings than the ankle plantarflexion device. The hip abduction device had the greatest ratio of metabolic savings to peak instantaneous positive device power, suggesting that frontal-plane hip assistance may be an efficient way to reduce metabolic cost. Overall, the device torque profiles generally differed from the corresponding net joint moment generated by muscles without assistance, and occasionally exceeded the net joint moment to reduce muscle activity at other degrees of freedom. Many devices affected the activity of muscles elsewhere in the limb; for example, the hip flexion device affected muscles that span the ankle joint. Our results may help experimentalists decide which joint motions to target when building devices and can provide intuition for how devices may interact with the musculoskeletal system. The simulations are freely available online, allowing others to reproduce and extend our work.

  4. Simulating ideal assistive devices to reduce the metabolic cost of walking with heavy loads

    PubMed Central

    Silder, Amy; Uchida, Thomas K.; Hicks, Jennifer L.; Delp, Scott L.

    2017-01-01

    Wearable robotic devices can restore and enhance mobility. There is growing interest in designing devices that reduce the metabolic cost of walking; however, designers lack guidelines for which joints to assist and when to provide the assistance. To help address this problem, we used musculoskeletal simulation to predict how hypothetical devices affect muscle activity and metabolic cost when walking with heavy loads. We explored 7 massless devices, each providing unrestricted torque at one degree of freedom in one direction (hip abduction, hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion, or ankle dorsiflexion). We used the Computed Muscle Control algorithm in OpenSim to find device torque profiles that minimized the sum of squared muscle activations while tracking measured kinematics of loaded walking without assistance. We then examined the metabolic savings provided by each device, the corresponding device torque profiles, and the resulting changes in muscle activity. We found that the hip flexion, knee flexion, and hip abduction devices provided greater metabolic savings than the ankle plantarflexion device. The hip abduction device had the greatest ratio of metabolic savings to peak instantaneous positive device power, suggesting that frontal-plane hip assistance may be an efficient way to reduce metabolic cost. Overall, the device torque profiles generally differed from the corresponding net joint moment generated by muscles without assistance, and occasionally exceeded the net joint moment to reduce muscle activity at other degrees of freedom. Many devices affected the activity of muscles elsewhere in the limb; for example, the hip flexion device affected muscles that span the ankle joint. Our results may help experimentalists decide which joint motions to target when building devices and can provide intuition for how devices may interact with the musculoskeletal system. The simulations are freely available online, allowing others to reproduce and extend our work. PMID:28700630

  5. A randomised control trial of prompt and feedback devices and their impact on quality of chest compressions--a simulation study.

    PubMed

    Yeung, Joyce; Davies, Robin; Gao, Fang; Perkins, Gavin D

    2014-04-01

    This study aims to compare the effect of three CPR prompt and feedback devices on quality of chest compressions amongst healthcare providers. A single blinded, randomised controlled trial compared a pressure sensor/metronome device (CPREzy), an accelerometer device (Phillips Q-CPR) and simple metronome on the quality of chest compressions on a manikin by trained rescuers. The primary outcome was compression depth. Secondary outcomes were compression rate, proportion of chest compressions with inadequate depth, incomplete release and user satisfaction. The pressure sensor device improved compression depth (37.24-43.64 mm, p=0.02), the accelerometer device decreased chest compression depth (37.38-33.19 mm, p=0.04) whilst the metronome had no effect (39.88 mm vs. 40.64 mm, p=0.802). Compression rate fell with all devices (pressure sensor device 114.68-98.84 min(-1), p=0.001, accelerometer 112.04-102.92 min(-1), p=0.072 and metronome 108.24 min(-1) vs. 99.36 min(-1), p=0.009). The pressure sensor feedback device reduced the proportion of compressions with inadequate depth (0.52 vs. 0.24, p=0.013) whilst the accelerometer device and metronome did not have a statistically significant effect. Incomplete release of compressions was common, but unaffected by the CPR feedback devices. Users preferred the accelerometer and metronome devices over the pressure sensor device. A post hoc study showed that de-activating the voice prompt on the accelerometer device prevented the deterioration in compression quality seen in the main study. CPR feedback devices vary in their ability to improve performance. In this study the pressure sensor device improved compression depth, whilst the accelerometer device reduced it and metronome had no effect. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  6. Tulip deformity with Cera atrial septal defect devices: a report of 3 cases.

    PubMed

    Kohli, Vikas

    2015-02-01

    Device closure of secundum atrial septal defect (ASD) is the treatment of choice when anatomy is favourable. Amplatzer device has remained the gold standard for closure of ASD. Cobra deformity is a well-reported problem with devices. Recently, Tulip deformity has been reported in a single case. We report a series of cases where we noted Tulip deformity along with inability to retract the device in the sheath in Cera Lifetech devices. This resulted in prolongation of procedure, excessive fluoroscopic exposure and additional interventional procedures not usually anticipated in ASD device closure. We believe that the problem is due to the stiffness of the device resulting in its inability to be retracted into the sheath. We also report a unique way of retrieving the device.

  7. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

    PubMed

    2017-10-20

    The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  8. Wireless device connection problems and design solutions

    NASA Astrophysics Data System (ADS)

    Song, Ji-Won; Norman, Donald; Nam, Tek-Jin; Qin, Shengfeng

    2016-09-01

    Users, especially the non-expert users, commonly experience problems when connecting multiple devices with interoperability. While studies on multiple device connections are mostly concentrated on spontaneous device association techniques with a focus on security aspects, the research on user interaction for device connection is still limited. More research into understanding people is needed for designers to devise usable techniques. This research applies the Research-through-Design method and studies the non-expert users' interactions in establishing wireless connections between devices. The "Learning from Examples" concept is adopted to develop a study focus line by learning from the expert users' interaction with devices. This focus line is then used for guiding researchers to explore the non-expert users' difficulties at each stage of the focus line. Finally, the Research-through-Design approach is used to understand the users' difficulties, gain insights to design problems and suggest usable solutions. When connecting a device, the user is required to manage not only the device's functionality but also the interaction between devices. Based on learning from failures, an important insight is found that the existing design approach to improve single-device interaction issues, such as improvements to graphical user interfaces or computer guidance, cannot help users to handle problems between multiple devices. This study finally proposes a desirable user-device interaction in which images of two devices function together with a system image to provide the user with feedback on the status of the connection, which allows them to infer any required actions.

  9. Study on intelligent processing system of man-machine interactive garment frame model

    NASA Astrophysics Data System (ADS)

    Chen, Shuwang; Yin, Xiaowei; Chang, Ruijiang; Pan, Peiyun; Wang, Xuedi; Shi, Shuze; Wei, Zhongqian

    2018-05-01

    A man-machine interactive garment frame model intelligent processing system is studied in this paper. The system consists of several sensor device, voice processing module, mechanical parts and data centralized acquisition devices. The sensor device is used to collect information on the environment changes brought by the body near the clothes frame model, the data collection device is used to collect the information of the environment change induced by the sensor device, voice processing module is used for speech recognition of nonspecific person to achieve human-machine interaction, mechanical moving parts are used to make corresponding mechanical responses to the information processed by data collection device.it is connected with data acquisition device by a means of one-way connection. There is a one-way connection between sensor device and data collection device, two-way connection between data acquisition device and voice processing module. The data collection device is one-way connection with mechanical movement parts. The intelligent processing system can judge whether it needs to interact with the customer, realize the man-machine interaction instead of the current rigid frame model.

  10. Method for accurately positioning a device at a desired area of interest

    DOEpatents

    Jones, Gary D.; Houston, Jack E.; Gillen, Kenneth T.

    2000-01-01

    A method for positioning a first device utilizing a surface having a viewing translation stage, the surface being movable between a first position where the viewing stage is in operational alignment with a first device and a second position where the viewing stage is in operational alignment with a second device. The movable surface is placed in the first position and an image is produced with the first device of an identifiable characteristic of a calibration object on the viewing stage. The moveable surface is then placed in the second position and only the second device is moved until an image of the identifiable characteristic in the second device matches the image from the first device. The calibration object is then replaced on the stage of the surface with a test object, and the viewing translation stage is adjusted until the second device images the area of interest. The surface is then moved to the first position where the test object is scanned with the first device to image the area of interest. An alternative embodiment where the devices move is also disclosed.

  11. Wind noise within and across behind-the-ear and miniature behind-the-ear hearing aids.

    PubMed

    Zakis, Justin A; Hawkins, Daniel J

    2015-10-01

    Previous studies investigated wind noise with Behind-The-Ear (BTE) hearing aids, but not the more common mini-BTE style of device, which typically has a smaller shell and microphones located more deeply behind the pinna. The current study investigated wind-noise levels across one BTE and two mini-BTE devices, and between the front and rear omni-directional microphones within devices. Levels were measured at two wind speeds (3 and 6 m/s) and 36 wind azimuths (10° increments). The pattern of wind-noise level versus azimuth was similar across mini-BTE devices, and differed for the BTE device. However, mean levels were markedly different across mini-BTE devices, and could be higher, lower, or similar to those of the BTE device. For within-device level differences, the pattern and mean across azimuth were similar across mini-BTE devices, and differed for the BTE device. Wind noise had the potential to slightly or severely reduce speech intelligibility at 3 or 6 m/s, respectively, across all devices.

  12. A sampling device with a capped body and detachable handle

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Jezek, Gerd-Rainer

    1997-12-01

    The present invention relates to a device for sampling radioactive waste and more particularly to a device for sampling radioactive waste which prevents contamination of a sampled material and the environment surrounding the sampled material. During vitrification of nuclear wastes, it is necessary to remove contamination from the surfaces of canisters filled with radioactive glass. After removal of contamination, a sampling device is used to test the surface of the canister. The one piece sampling device currently in use creates a potential for spreading contamination during vitrification operations. During operations, the one piece sampling device is transferred into and outmore » of the vitrification cell through a transfer drawer. Inside the cell, a remote control device handles the sampling device to wipe the surface of the canister. A one piece sampling device can be contaminated by the remote control device prior to use. Further, the sample device can also contaminate the transfer drawer producing false readings for radioactive material. The present invention overcomes this problem by enclosing the sampling pad in a cap. The removable handle is reused which reduces the amount of waste material.« less

  13. Electro-optic component mounting device

    DOEpatents

    Gruchalla, M.E.

    1994-09-13

    A technique is provided for integrally mounting a device such as an electro-optic device in a transmission line to avoid series resonant effects. A center conductor of the transmission line has an aperture formed therein for receiving the device. The aperture splits the center conductor into two parallel sections on opposite sides of the device. For a waveguide application, the center conductor is surrounded by a conductive ground surface which is spaced apart from the center conductor with a dielectric material. One set of electrodes formed on the surface of the electro-optic device is directly connected to the center conductor and an electrode formed on the surface of the electro-optic device is directly connected to the conductive ground surface. The electrodes formed on the surface of the electro-optic device are formed on curved sections of the surface of the device to mate with correspondingly shaped electrodes on the conductor and ground surface to provide a uniform electric field across the electro-optic device. The center conductor includes a passage formed therein for passage of optical signals to an electro-optic device. 10 figs.

  14. Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

    PubMed

    2004-03-16

    The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

  15. Evaluation of semiconductor devices for Electric and Hybrid Vehicle (EHV) ac-drive applications, volume 1

    NASA Technical Reports Server (NTRS)

    Lee, F. C.; Chen, D. Y.; Jovanovic, M.; Hopkins, D. C.

    1985-01-01

    The results of evaluation of power semiconductor devices for electric hybrid vehicle ac drive applications are summarized. Three types of power devices are evaluated in the effort: high power bipolar or Darlington transistors, power MOSFETs, and asymmetric silicon control rectifiers (ASCR). The Bipolar transistors, including discrete device and Darlington devices, range from 100 A to 400 A and from 400 V to 900 V. These devices are currently used as key switching elements inverters for ac motor drive applications. Power MOSFETs, on the other hand, are much smaller in current rating. For the 400 V device, the current rating is limited to 25 A. For the main drive of an electric vehicle, device paralleling is normally needed to achieve practical power level. For other electric vehicle (EV) related applications such as battery charger circuit, however, MOSFET is advantageous to other devices because of drive circuit simplicity and high frequency capability. Asymmetrical SCR is basically a SCR device and needs commutation circuit for turn off. However, the device poses several advantages, i.e., low conduction drop and low cost.

  16. The use of medication compliance devices by district nursing services.

    PubMed

    McGraw, C; Drennan, V

    2000-07-01

    This article presents a critical review of the literature relating to medication compliance devices and the findings of a survey that examined the use of such devices by district nursing services. The UKCC (1992) does not regard the loading of compliance devices by nurses as safe practice; however, compliance devices continue to be used by district nurses. The evidence base concerning the value and use of medication compliance devices is examined and significant gaps in the literature relating to the use of such devices are identified. There is an absence of studies that focus on the effect of compliance devices on adherence among older patients and the nature and frequency of drug administration errors involving these devices. The survey findings show that nurse-loaded compliance devices are used in over one-third of the sample. Further research is necessary to assess the clinical effectiveness of, and clinical risk attached to, compliance devices for older patients in the community. It is suggested that this is an issue of serious concern for primary care groups considering the principles of clinical governance.

  17. Spin pumping driven auto-oscillator for phase-encoded logic—device design and material requirements

    NASA Astrophysics Data System (ADS)

    Rakheja, S.; Kani, N.

    2017-05-01

    In this work, we propose a spin nano-oscillator (SNO) device where information is encoded in the phase (time-shift) of the output oscillations. The spin current required to set up the oscillations in the device is generated through spin pumping from an input nanomagnet that is precessing at RF frequencies. We discuss the operation of the SNO device, in which either the in-plane (IP) or out-of-plane (OOP) magnetization oscillations are utilized toward implementing ultra-low-power circuits. Using physical models of the nanomagnet dynamics and the spin transport through non-magnetic channels, we quantify the reliability of the SNO device using a "scaling ratio". Material requirements for the nanomagnet and the channel to ensure correct logic functionality are identified using the scaling ratio metric. SNO devices consume (2-5)× lower energy compared to CMOS devices and other spin-based devices with similar device sizes and material parameters. The analytical models presented in this work can be used to optimize the performance and scaling of SNO devices in comparison to CMOS devices at ultra-scaled technology nodes.

  18. Gold nanostructures and methods of use

    DOEpatents

    Zhang, Jin Z [Santa Cruz, CA; Schwartzberg, Adam [Santa Cruz, CA; Olson, Tammy Y [Santa Cruz, CA

    2012-03-20

    The invention is drawn to novel nanostructures comprising hollow nanospheres and nanotubes for use as chemical sensors, conduits for fluids, and electronic conductors. The nanostructures can be used in microfluidic devices, for transporting fluids between devices and structures in analytical devices, for conducting electrical currents between devices and structure in analytical devices, and for conducting electrical currents between biological molecules and electronic devices, such as bio-microchips.

  19. Connector device for building integrated photovoltaic device

    DOEpatents

    Keenihan, James R.; Langmaid, Joe A.; Eurich, Gerald K.; Lesniak, Michael J.; Mazor, Michael H.; Cleerman, Robert J.; Gaston, Ryan S.

    2015-11-10

    The present invention is premised upon a connector device and method that can more easily electrically connect a plurality of PV devices or photovoltaic system components and/or locate these devices/components upon a building structure. It also may optionally provide some additional sub-components (e.g. at least one bypass diode and/or an indicator means) and may enhance the serviceability of the device.

  20. Connector device for building integrated photovoltaic device

    DOEpatents

    Keenihan, James R.; Langmaid, Joseph A.; Eurich, Gerald K.; Lesniak, Michael J.; Mazor, Michael H.; Cleereman, Robert J.; Gaston, Ryan S.

    2014-06-03

    The present invention is premised upon a connector device and method that can more easily electrically connect a plurality of PV devices or photovoltaic system components and/or locate these devices/components upon a building structure. It also may optionally provide some additional sub-components (e.g. at least one bypass diode and/or an indicator means) and may enhance the serviceability of the device.

  1. Energy management system for a rotary machine and method therefor

    DOEpatents

    Bowman, Michael John; Sinha, Gautam; Sheldon, Karl Edward

    2004-11-09

    In energy management system is provided for a power generating device having a working fluid intake in which the energy management system comprises an electrical dissipation device coupled to the power generating device and a dissipation device cooling system configured to direct a portion of a working fluid to the electrical dissipation device so as to provide thermal control to the electrical dissipation device.

  2. Gold nanostructures and methods of use

    DOEpatents

    Zhang, Jin Z.; Schwartzberg, Adam; Olson, Tammy Y.

    2016-03-01

    The invention is drawn to novel nanostructures comprising hollow nanospheres and nanotubes for use as chemical sensors, conduits for fluids, and electronic conductors. The nanostructures can be used in microfluidic devices, for transporting fluids between devices and structures in analytical devices, for conducting electrical currents between devices and structure in analytical devices, and for conducting electrical currents between biological molecules and electronic devices, such as bio-microchips.

  3. Shape Memory Actuation and Release Devices.

    DTIC Science & Technology

    1996-10-01

    shelf devices such as pyrotechnics, gas-discharge systems, paraffin wax actuators, and other electro-mechanical devices may not be able to meet...shelf devices such as pyrotechnics, gas-discharge systems, paraffin wax actuators, and other electro-mechanical devices may not be able to meet future...shard mounts. They do have wide utility as pin-pullers and single point release devices for a variety of spacecraft appendages. Parrafin based mechanisms

  4. Smart portable rehabilitation devices.

    PubMed

    Mavroidis, Constantinos; Nikitczuk, Jason; Weinberg, Brian; Danaher, Gil; Jensen, Katherine; Pelletier, Philip; Prugnarola, Jennifer; Stuart, Ryan; Arango, Roberto; Leahey, Matt; Pavone, Robert; Provo, Andrew; Yasevac, Dan

    2005-07-12

    The majority of current portable orthotic devices and rehabilitative braces provide stability, apply precise pressure, or help maintain alignment of the joints with out the capability for real time monitoring of the patient's motions and forces and without the ability for real time adjustments of the applied forces and motions. Improved technology has allowed for advancements where these devices can be designed to apply a form of tension to resist motion of the joint. These devices induce quicker recovery and are more effective at restoring proper biomechanics and improving muscle function. However, their shortcoming is in their inability to be adjusted in real-time, which is the most ideal form of a device for rehabilitation. This introduces a second class of devices beyond passive orthotics. It is comprised of "active" or powered devices, and although more complicated in design, they are definitely the most versatile. An active or powered orthotic, usually employs some type of actuator(s). In this paper we present several new advancements in the area of smart rehabilitation devices that have been developed by the Northeastern University Robotics and Mechatronics Laboratory. They are all compact, wearable and portable devices and boast re-programmable, real time computer controlled functions as the central theme behind their operation. The sensory information and computer control of the three described devices make for highly efficient and versatile systems that represent a whole new breed in wearable rehabilitation devices. Their applications range from active-assistive rehabilitation to resistance exercise and even have applications in gait training. The three devices described are: a transportable continuous passive motion elbow device, a wearable electro-rheological fluid based knee resistance device, and a wearable electrical stimulation and biofeedback knee device. Laboratory tests of the devices demonstrated that they were able to meet their design objectives. The prototypes of portable rehabilitation devices presented here did demonstrate that these concepts are capable of the performance their commercially available but non-portable counterparts exhibit. Smart, portable devices with the ability for real time monitoring and adjustment open a new era in rehabilitation where the recovery process could be dramatically improved.

  5. Smart portable rehabilitation devices

    PubMed Central

    Mavroidis, Constantinos; Nikitczuk, Jason; Weinberg, Brian; Danaher, Gil; Jensen, Katherine; Pelletier, Philip; Prugnarola, Jennifer; Stuart, Ryan; Arango, Roberto; Leahey, Matt; Pavone, Robert; Provo, Andrew; Yasevac, Dan

    2005-01-01

    Background The majority of current portable orthotic devices and rehabilitative braces provide stability, apply precise pressure, or help maintain alignment of the joints with out the capability for real time monitoring of the patient's motions and forces and without the ability for real time adjustments of the applied forces and motions. Improved technology has allowed for advancements where these devices can be designed to apply a form of tension to resist motion of the joint. These devices induce quicker recovery and are more effective at restoring proper biomechanics and improving muscle function. However, their shortcoming is in their inability to be adjusted in real-time, which is the most ideal form of a device for rehabilitation. This introduces a second class of devices beyond passive orthotics. It is comprised of "active" or powered devices, and although more complicated in design, they are definitely the most versatile. An active or powered orthotic, usually employs some type of actuator(s). Methods In this paper we present several new advancements in the area of smart rehabilitation devices that have been developed by the Northeastern University Robotics and Mechatronics Laboratory. They are all compact, wearable and portable devices and boast re-programmable, real time computer controlled functions as the central theme behind their operation. The sensory information and computer control of the three described devices make for highly efficient and versatile systems that represent a whole new breed in wearable rehabilitation devices. Their applications range from active-assistive rehabilitation to resistance exercise and even have applications in gait training. The three devices described are: a transportable continuous passive motion elbow device, a wearable electro-rheological fluid based knee resistance device, and a wearable electrical stimulation and biofeedback knee device. Results Laboratory tests of the devices demonstrated that they were able to meet their design objectives. The prototypes of portable rehabilitation devices presented here did demonstrate that these concepts are capable of the performance their commercially available but non-portable counterparts exhibit. Conclusion Smart, portable devices with the ability for real time monitoring and adjustment open a new era in rehabilitation where the recovery process could be dramatically improved. PMID:16011801

  6. [Innovation of characteristic medicinal cupping devices].

    PubMed

    Li, Jianping; Zhang, Hui; Yang, Jianmei; Xu, Xinchun; Niu, Yanxia; Cai, Jun

    2015-08-01

    To compare the differences in the characteristic medicinal cupping therapy between the traditional cupping device and the innovated cupping device. Fifty patients of neck and low back pain were selected. The self-comparison was adopted. The cupping therapy was applied to the acupoints located on the left or right side with the traditional cupping device and the innovated cupping device. The cupping sites were centered at bilateral Quyuan (SI 13) and Dachangshu (BL 25). The cups were retained for 10 min. The traditional cupping device was the glass with smooth border, 100mL. The innovated cupping device was the vacuum-sucking cup. The operative time, medicinal leakage, comfort and cupping marks were observed for the two different cupping devices. The operative time with the innovated medicinal cupping device was shorter obviously compared with the traditional one at Quyuan (SI 13) and Dachangshu (BL 25, both P<0. 05). The comfort with the innovated medicinal cupping device was remarkably improved as compared with the traditional one at the two acupoints (both P<0. 05). The medicinal leakage was similar between the two different devices during the cupping operation (both P>0. 05). The cupping marks with the innovated medicinal cupping device were much deeper than those with the traditional one after cupping therapy. The innovated cupping device is more convenent and comfortable in operation during the characteristic medicinal cupping therapy.

  7. The RFET—a reconfigurable nanowire transistor and its application to novel electronic circuits and systems

    NASA Astrophysics Data System (ADS)

    Mikolajick, T.; Heinzig, A.; Trommer, J.; Baldauf, T.; Weber, W. M.

    2017-04-01

    With CMOS scaling reaching physical limits in the next decade, new approaches are required to enhance the functionality of electronic systems. Reconfigurability on the device level promises to realize more complex systems with a lower device count. In the last five years a number of interesting concepts have been proposed to realize such a device level reconfiguration. Among these the reconfigurable field effect transistor (RFET), a device that can be configured between an n-channel and p-channel behavior by applying an electrical signal, can be considered as an end-of-roadmap extension of current technology with only small modifications and even simplifications to the process flow. This article gives a review on the RFET basics and current status. In the first sections state-of-the-art of reconfigurable devices will be summarized and the RFET will be introduced together with related devices based on silicon nanowire technology. The device optimization with respect to device symmetry and performance will be discussed next. The potential of the RFET device technology will then be shown by discussing selected circuit implementations making use of the unique advantages of this device concept. The basic device concept was also extended towards applications in flexible devices and sensors, also extending the capabilities towards so-called More-than-Moore applications where new functionalities are implemented in CMOS-based processes. Finally, the prospects of RFET device technology will be discussed.

  8. Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices That Require Electricity

    MedlinePlus

    ... Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices and Rad lth ... Handle Power Outages for Medical Devices that Require Electricity As a home medical device user, it is ...

  9. 21 CFR 882.1570 - Powered direct-contact temperature measurement device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered direct-contact temperature measurement... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1570 Powered direct-contact temperature measurement device. (a) Identification. A powered direct...

  10. 21 CFR 882.1570 - Powered direct-contact temperature measurement device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered direct-contact temperature measurement... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1570 Powered direct-contact temperature measurement device. (a) Identification. A powered direct...

  11. 21 CFR 882.1570 - Powered direct-contact temperature measurement device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered direct-contact temperature measurement... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1570 Powered direct-contact temperature measurement device. (a) Identification. A powered direct...

  12. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ...] Medical Device Innovation Initiative; Public Meeting; Request for Comments AGENCY: Food and Drug... Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public... Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative...

  13. 47 CFR 15.303 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... measurement. (d) Isochronous devices. Devices that transmit at a regular interval, typified by time-division... Communications Service Devices § 15.303 Definitions. (a) Asynchronous devices. Devices that transmit RF energy at... with a fixed infrastructure or by disabling mechanisms to allow adequate coordination of their...

  14. 21 CFR 886.1700 - Pupillometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... eye. (b) Classification. Class I (general controls). The AC-powered device and the manual device are... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1700 Pupillometer. (a) Identification. A pupillometer is an AC...

  15. Device characteristics of antenna-coupled metal-insulator-metal diodes (rectenna) using Al2O3, TiO2, and Cr2O3 as insulator layer for energy harvesting applications

    NASA Astrophysics Data System (ADS)

    Inac, Mesut; Shafique, Atia; Ozcan, Meric; Gurbuz, Yasar

    2015-09-01

    Antenna-coupled metal-insulator-metal devices are most potent candidate for future energy harvesting devices. The reason for that they are ultra-high speed devices that can rectify the electromagnetic radiation at high frequencies. In addition to their speed, they are also small devices that can have more number of devices in unit area. In this work, it is aimed design and develop a device which can harvest and detect IR radiation.

  16. Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

    PubMed

    2014-10-22

    The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

  17. Method and apparatus for actively controlling a micro-scale flexural plate wave device

    DOEpatents

    Dohner, Jeffrey L.

    2001-01-01

    An actively controlled flexural plate wave device provides a micro-scale pump. A method of actively controlling a flexural plate wave device produces traveling waves in the device by coordinating the interaction of a magnetic field with actively controlled currents. An actively-controlled flexural plate wave device can be placed in a fluid channel and adapted for use as a micro-scale fluid pump to cool or drive micro-scale systems, for example, micro-chips, micro-electrical-mechanical devices, micro-fluid circuits, or micro-scale chemical analysis devices.

  18. Communicating with residential electrical devices via a vehicle telematics unit

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Roth, Rebecca C.; Pebbles, Paul H.

    A method of communicating with residential electrical devices using a vehicle telematics unit includes receiving information identifying a residential electrical device to control; displaying in a vehicle one or more controlled features of the identified residential electrical device; receiving from a vehicle occupant a selection of the displayed controlled features of the residential electrical device; sending an instruction from the vehicle telematics unit to the residential electrical device via a wireless carrier system in response to the received selection; and controlling the residential electrical device using the sent instruction.

  19. Technique for calibrating angular measurement devices when calibration standards are unavailable

    NASA Technical Reports Server (NTRS)

    Finley, Tom D.

    1991-01-01

    A calibration technique is proposed that will allow the calibration of certain angular measurement devices without requiring the use of absolute standard. The technique assumes that the device to be calibrated has deterministic bias errors. A comparison device must be available that meets the same requirements. The two devices are compared; one device is then rotated with respect to the other, and a second comparison is performed. If the data are reduced using the described technique, the individual errors of the two devices can be determined.

  20. Method for integrating microelectromechanical devices with electronic circuitry

    DOEpatents

    Montague, S.; Smith, J.H.; Sniegowski, J.J.; McWhorter, P.J.

    1998-08-25

    A method is disclosed for integrating one or more microelectromechanical (MEM) devices with electronic circuitry. The method comprises the steps of forming each MEM device within a cavity below a device surface of the substrate; encapsulating the MEM device prior to forming electronic circuitry on the substrate; and releasing the MEM device for operation after fabrication of the electronic circuitry. Planarization of the encapsulated MEM device prior to formation of the electronic circuitry allows the use of standard processing steps for fabrication of the electronic circuitry. 13 figs.

  1. All APAPs Are Not Equivalent for the Treatment of Sleep Disordered Breathing: A Bench Evaluation of Eleven Commercially Available Devices

    PubMed Central

    Zhu, Kaixian; Roisman, Gabriel; Aouf, Sami; Escourrou, Pierre

    2015-01-01

    Study Objectives: This study challenged on a bench-test the efficacy of auto-titrating positive airway pressure (APAP) devices for obstructive sleep disordered breathing treatment and evaluated the accuracy of the device reports. Methods: Our bench consisted of an active lung simulator and a Starling resistor. Eleven commercially available APAP devices were evaluated on their reactions to single-type SDB sequences (obstructive apnea and hypopnea, central apnea, and snoring), and to a long general breathing scenario (5.75 h) simulating various SDB during four sleep cycles and to a short scenario (95 min) simulating one sleep cycle. Results: In the single-type sequence of 30-minute repetitive obstructive apneas, only 5 devices normalized the airflow (> 70% of baseline breathing amplitude). Similarly, normalized breathing was recorded with 8 devices only for a 20-min obstructive hypopnea sequence. Five devices increased the pressure in response to snoring. Only 4 devices maintained a constant minimum pressure when subjected to repeated central apneas with an open upper airway. In the long general breathing scenario, the pressure responses and the treatment efficacy differed among devices: only 5 devices obtained a residual obstructive AHI < 5/h. During the short general breathing scenario, only 2 devices reached the same treatment efficacy (p < 0.001), and 3 devices underestimated the AHI by > 10% (p < 0.001). The long scenario led to more consistent device reports. Conclusion: Large differences between APAP devices in the treatment efficacy and the accuracy of report were evidenced in the current study. Citation: Zhu K, Roisman G, Aouf S, Escourrou P. All APAPs are not equivalent for the treatment of sleep disordered breathing: a bench evaluation of eleven commercially available devices. J Clin Sleep Med 2015;11(7):725–734. PMID:25766708

  2. Fabrication and testing of unileg oxide thermoelectric device

    NASA Astrophysics Data System (ADS)

    Sharma, Jyothi; Purohit, R. D.; Prakash, Deep; Sinha, P. K.

    2017-05-01

    A prototype of oxide thermoelectric unileg device was fabricated. This device was based on only n-legs made of La doped calcium manganate. The powder was synthesized, characterised and consolidated in rectangular thermoelements. A 3×3 device was fabricated by fitting 9 rectangular bars in alumina housing and connected by silver strips. The device has been tested under large temperature difference (ΔT=480°C) using an indegenous system. An open circuit voltage of 468 mV was obtained for a nine leg `unileg' device. The device exhibits a internal resistance of ˜1Ω. The maximum power output for this nine leg device reached upto 50 mW in these working condition.

  3. Implantable biomedical devices on bioresorbable substrates

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rogers, John A; Kim, Dae-Hyeong; Omenetto, Fiorenzo

    Provided herein are implantable biomedical devices, methods of administering implantable biomedical devices, methods of making implantable biomedical devices, and methods of using implantable biomedical devices to actuate a target tissue or sense a parameter associated with the target tissue in a biological environment. Each implantable biomedical device comprises a bioresorbable substrate, an electronic device having a plurality of inorganic semiconductor components supported by the bioresorbable substrate, and a barrier layer encapsulating at least a portion of the inorganic semiconductor components. Upon contact with a biological environment the bioresorbable substrate is at least partially resorbed, thereby establishing conformal contact between themore » implantable biomedical device and the target tissue in the biological environment.« less

  4. A DRM based on renewable broadcast encryption

    NASA Astrophysics Data System (ADS)

    Ramkumar, Mahalingam; Memon, Nasir

    2005-07-01

    We propose an architecture for digital rights management based on a renewable, random key pre-distribution (KPD) scheme, HARPS (hashed random preloaded subsets). The proposed architecture caters for broadcast encryption by a trusted authority (TA) and by "parent" devices (devices used by vendors who manufacture compliant devices) for periodic revocation of devices. The KPD also facilitates broadcast encryption by peer devices, which permits peers to distribute content, and efficiently control access to the content encryption secret using subscription secrets. The underlying KPD also caters for broadcast authentication and mutual authentication of any two devices, irrespective of the vendors manufacturing the device, and thus provides a comprehensive solution for securing interactions between devices taking part in a DRM system.

  5. Separating semiconductor devices from substrate by etching graded composition release layer disposed between semiconductor devices and substrate including forming protuberances that reduce stiction

    DOEpatents

    Tauke-Pedretti, Anna; Nielson, Gregory N; Cederberg, Jeffrey G; Cruz-Campa, Jose Luis

    2015-05-12

    A method includes etching a release layer that is coupled between a plurality of semiconductor devices and a substrate with an etch. The etching includes etching the release layer between the semiconductor devices and the substrate until the semiconductor devices are at least substantially released from the substrate. The etching also includes etching a protuberance in the release layer between each of the semiconductor devices and the substrate. The etch is stopped while the protuberances remain between each of the semiconductor devices and the substrate. The method also includes separating the semiconductor devices from the substrate. Other methods and apparatus are also disclosed.

  6. System and method for evaluating wind flow fields using remote sensing devices

    DOEpatents

    Schroeder, John; Hirth, Brian; Guynes, Jerry

    2016-12-13

    The present invention provides a system and method for obtaining data to determine one or more characteristics of a wind field using a first remote sensing device and a second remote sensing device. Coordinated data is collected from the first and second remote sensing devices and analyzed to determine the one or more characteristics of the wind field. The first remote sensing device is positioned to have a portion of the wind field within a first scanning sector of the first remote sensing device. The second remote sensing device is positioned to have the portion of the wind field disposed within a second scanning sector of the second remote sensing device.

  7. Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery.

    PubMed

    Tom, James

    2016-01-01

    The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias.

  8. Management of Patients With Cardiovascular Implantable Electronic Devices in Dental, Oral, and Maxillofacial Surgery

    PubMed Central

    Tom, James

    2016-01-01

    The prevalence of cardiovascular implantable electronic devices as life-prolonging and life-saving devices has evolved from a treatment of last resort to a first-line therapy for an increasing number of patients. As these devices become more and more popular in the general population, dental providers utilizing instruments and medications should be aware of dental equipment and medications that may affect these devices and understand the management of patients with these devices. This review article will discuss the various types and indications for pacemakers and implantable cardioverter-defibrillators, common drugs and instruments affecting these devices, and management of patients with these devices implanted for cardiac dysrhythmias. PMID:27269668

  9. Systems, methods and apparatus for quiesence of autonomic safety devices with self action

    NASA Technical Reports Server (NTRS)

    Hinchey, Michael G. (Inventor); Sterritt, Roy (Inventor)

    2011-01-01

    Systems, methods and apparatus are provided through which in some embodiments an autonomic environmental safety device may be quiesced. In at least one embodiment, a method for managing an autonomic safety device, such as a smoke detector, based on functioning state and operating status of the autonomic safety device includes processing received signals from the autonomic safety device to obtain an analysis of the condition of the autonomic safety device, generating one or more stay-awake signals based on the functioning status and the operating state of the autonomic safety device, transmitting the stay-awake signal, transmitting self health/urgency data, and transmitting environment health/urgency data. A quiesce component of an autonomic safety device can render the autonomic safety device inactive for a specific amount of time or until a challenging situation has passed.

  10. Graphene device and method of using graphene device

    DOEpatents

    Bouchiat, Vincent; Girit, Caglar; Kessler, Brian; Zettl, Alexander K.

    2015-08-11

    An embodiment of a graphene device includes a layered structure, first and second electrodes, and a dopant island. The layered structure includes a conductive layer, an insulating layer, and a graphene layer. The electrodes are coupled to the graphene layer. The dopant island is coupled to an exposed surface of the graphene layer between the electrodes. An embodiment of a method of using a graphene device includes providing the graphene device. A voltage is applied to the conductive layer of the graphene device. Another embodiment of a method of using a graphene device includes providing the graphene device without the dopant island. A dopant island is placed on an exposed surface of the graphene layer between the electrodes. A voltage is applied to the conductive layer of the graphene device. A response of the dopant island to the voltage is observed.

  11. Dynamic mapping of EDDL device descriptions to OPC UA

    NASA Astrophysics Data System (ADS)

    Atta Nsiah, Kofi; Schappacher, Manuel; Sikora, Axel

    2017-07-01

    OPC UA (Open Platform Communications Unified Architecture) is already a well-known concept used widely in the automation industry. In the area of factory automation, OPC UA models the underlying field devices such as sensors and actuators in an OPC UA server to allow connecting OPC UA clients to access device-specific information via a standardized information model. One of the requirements of the OPC UA server to represent field device data using its information model is to have advanced knowledge about the properties of the field devices in the form of device descriptions. The international standard IEC 61804 specifies EDDL (Electronic Device Description Language) as a generic language for describing the properties of field devices. In this paper, the authors describe a possibility to dynamically map and integrate field device descriptions based on EDDL into OPCUA.

  12. Clocked Magnetostriction-Assisted Spintronic Device Design and Simulation

    NASA Astrophysics Data System (ADS)

    Mousavi Iraei, Rouhollah; Kani, Nickvash; Dutta, Sourav; Nikonov, Dmitri E.; Manipatruni, Sasikanth; Young, Ian A.; Heron, John T.; Naeemi, Azad

    2018-05-01

    We propose a heterostructure device comprised of magnets and piezoelectrics that significantly improves the delay and the energy dissipation of an all-spin logic (ASL) device. This paper studies and models the physics of the device, illustrates its operation, and benchmarks its performance using SPICE simulations. We show that the proposed device maintains low voltage operation, non-reciprocity, non-volatility, cascadability, and thermal reliability of the original ASL device. Moreover, by utilizing the deterministic switching of a magnet from the saddle point of the energy profile, the device is more efficient in terms of energy and delay and is robust to thermal fluctuations. The results of simulations show that compared to ASL devices, the proposed device achieves 21x shorter delay and 27x lower energy dissipation per bit for a 32-bit arithmetic-logic unit (ALU).

  13. 21 CFR 882.5235 - Aversive conditioning device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Aversive conditioning device. 882.5235 Section 882.5235 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5235 Aversive conditioning...

  14. 21 CFR 882.5235 - Aversive conditioning device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Aversive conditioning device. 882.5235 Section 882.5235 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5235 Aversive conditioning...

  15. 21 CFR 870.3300 - Vascular embolization device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vascular embolization device. 870.3300 Section 870.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3300 Vascular embolization...

  16. 21 CFR 866.2660 - Microorganism differentiation and identification device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microorganism differentiation and identification device. 866.2660 Section 866.2660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  17. 21 CFR 866.2660 - Microorganism differentiation and identification device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Microorganism differentiation and identification device. 866.2660 Section 866.2660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  18. 21 CFR 866.2660 - Microorganism differentiation and identification device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Microorganism differentiation and identification device. 866.2660 Section 866.2660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  19. 21 CFR 866.2660 - Microorganism differentiation and identification device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Microorganism differentiation and identification device. 866.2660 Section 866.2660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  20. 21 CFR 866.2660 - Microorganism differentiation and identification device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Microorganism differentiation and identification device. 866.2660 Section 866.2660 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  1. 21 CFR 890.5525 - Iontophoresis device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Iontophoresis device. 890.5525 Section 890.5525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5525 Iontophoresis...

  2. 21 CFR 890.5525 - Iontophoresis device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Iontophoresis device. 890.5525 Section 890.5525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5525 Iontophoresis...

  3. 21 CFR 890.5525 - Iontophoresis device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Iontophoresis device. 890.5525 Section 890.5525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5525 Iontophoresis...

  4. 21 CFR 890.5525 - Iontophoresis device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Iontophoresis device. 890.5525 Section 890.5525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5525 Iontophoresis...

  5. 21 CFR 890.5525 - Iontophoresis device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Iontophoresis device. 890.5525 Section 890.5525 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5525 Iontophoresis...

  6. 16 CFR 1507.8 - Wheel devices.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Wheel devices. 1507.8 Section 1507.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS FIREWORKS DEVICES § 1507.8 Wheel devices. Drivers in fireworks devices commonly known as “wheels” shall be...

  7. 21 CFR 870.3300 - Vascular embolization device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular embolization device. 870.3300 Section 870.3300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3300 Vascular embolization...

  8. 21 CFR 886.1660 - Gonioscopic prism.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1660 Gonioscopic prism. (a) Identification. A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features. (b...

  9. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

  10. 21 CFR 886.1380 - Diagnostic condensing lens.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... light from the fundus of the eye. (b) Classification. Class I (general controls). The device is exempt...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure...

  11. 21 CFR 892.1 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.1 Scope. (a) This part sets forth the classification of radiology devices... devices, as required by § 807.87. (c) To avoid duplicative listings, a radiology device that has two or...

  12. A New Tool for Assessing Mobile Device Proficiency in Older Adults: The Mobile Device Proficiency Questionnaire.

    PubMed

    Roque, Nelson A; Boot, Walter R

    2018-02-01

    Mobile device proficiency is increasingly required to participate in society. Unfortunately, there still exists a digital divide between younger and older adults, especially with respect to mobile devices (i.e., tablet computers and smartphones). Training is an important goal to ensure that older adults can reap the benefits of these devices. However, efficient/effective training depends on the ability to gauge current proficiency levels. We developed a new scale to accurately assess the mobile device proficiency of older adults: the Mobile Device Proficiency Questionnaire (MDPQ). We present and validate the MDPQ and a short 16-question version of the MDPQ (MDPQ-16). The MDPQ, its subscales, and the MDPQ-16 were found to be highly reliable and valid measures of mobile device proficiency in a large sample. We conclude that the MDPQ and MDPQ-16 may serve as useful tools for facilitating mobile device training of older adults and measuring mobile device proficiency for research purposes.

  13. Memory attacks on device-independent quantum cryptography.

    PubMed

    Barrett, Jonathan; Colbeck, Roger; Kent, Adrian

    2013-01-04

    Device-independent quantum cryptographic schemes aim to guarantee security to users based only on the output statistics of any components used, and without the need to verify their internal functionality. Since this would protect users against untrustworthy or incompetent manufacturers, sabotage, or device degradation, this idea has excited much interest, and many device-independent schemes have been proposed. Here we identify a critical weakness of device-independent protocols that rely on public communication between secure laboratories. Untrusted devices may record their inputs and outputs and reveal information about them via publicly discussed outputs during later runs. Reusing devices thus compromises the security of a protocol and risks leaking secret data. Possible defenses include securely destroying or isolating used devices. However, these are costly and often impractical. We propose other more practical partial defenses as well as a new protocol structure for device-independent quantum key distribution that aims to achieve composable security in the case of two parties using a small number of devices to repeatedly share keys with each other (and no other party).

  14. S-Band POSIX Device Drivers for RTEMS

    NASA Technical Reports Server (NTRS)

    Lux, James P.; Lang, Minh; Peters, Kenneth J.; Taylor, Gregory H.

    2011-01-01

    This is a set of POSIX device driver level abstractions in the RTEMS RTOS (Real-Time Executive for Multiprocessor Systems real-time operating system) to SBand radio hardware devices that have been instantiated in an FPGA (field-programmable gate array). These include A/D (analog-to-digital) sample capture, D/A (digital-to-analog) sample playback, PLL (phase-locked-loop) tuning, and PWM (pulse-width-modulation)-controlled gain. This software interfaces to Sband radio hardware in an attached Xilinx Virtex-2 FPGA. It uses plug-and-play device discovery to map memory to device IDs. Instead of interacting with hardware devices directly, using direct-memory mapped access at the application level, this driver provides an application programming interface (API) offering that easily uses standard POSIX function calls. This simplifies application programming, enables portability, and offers an additional level of protection to the hardware. There are three separate device drivers included in this package: sband_device (ADC capture and DAC playback), pll_device (RF front end PLL tuning), and pwm_device (RF front end AGC control).

  15. Simultaneous acquisition of differing image types

    DOEpatents

    Demos, Stavros G

    2012-10-09

    A system in one embodiment includes an image forming device for forming an image from an area of interest containing different image components; an illumination device for illuminating the area of interest with light containing multiple components; at least one light source coupled to the illumination device, the at least one light source providing light to the illumination device containing different components, each component having distinct spectral characteristics and relative intensity; an image analyzer coupled to the image forming device, the image analyzer decomposing the image formed by the image forming device into multiple component parts based on type of imaging; and multiple image capture devices, each image capture device receiving one of the component parts of the image. A method in one embodiment includes receiving an image from an image forming device; decomposing the image formed by the image forming device into multiple component parts based on type of imaging; receiving the component parts of the image; and outputting image information based on the component parts of the image. Additional systems and methods are presented.

  16. Encapsulation methods for organic electrical devices

    DOEpatents

    Blum, Yigal D.; Chu, William Siu-Keung; MacQueen, David Brent; Shi, Yijian

    2013-06-18

    The disclosure provides methods and materials suitable for use as encapsulation barriers in electronic devices. In one embodiment, for example, there is provided an electroluminescent device or other electronic device encapsulated by alternating layers of a silicon-containing bonding material and a ceramic material. The encapsulation methods provide, for example, electronic devices with increased stability and shelf-life. The invention is useful, for example, in the field of microelectronic devices.

  17. Nonlinear Optical Acrylic Polymers and Use Thereof in Optical and Electro-Optic Devices

    DTIC Science & Technology

    1992-01-07

    COVERED 4. TITLE AND SUBTITLE Nonlinear Optical Acrylic Polymers and Use Thereof in Optical and Electro - Optic Devices 5a. CONTRACT NUMBER 5b. GRANT...generators, computational devices and the like. 15. SUBJECT TERMS optical devices, electro - optical devices, optical signal processing...THEREOF IN OPTICAL AND ELECTRO - OPTIC DEVICES [75] Inventors: Le*lie H. Sperling, Bethlehem; Clarence J. Murphy, Stroudsburg; Warren A. Rosen

  18. Upconverting device for enhanced recogntion of certain wavelengths of light

    DOEpatents

    Kross, Brian; McKIsson, John E; McKisson, John; Weisenberger, Andrew; Xi, Wenze; Zorn, Carl

    2013-05-21

    An upconverting device for enhanced recognition of selected wavelengths is provided. The device comprises a transparent light transmitter in combination with a plurality of upconverting nanoparticles. The device may a lens in eyewear or alternatively a transparent panel such as a window in an instrument or machine. In use the upconverting device is positioned between a light source and the eye(s) of the user of the upconverting device.

  19. Overview of Robotic Devices for Nursing Care Project.

    PubMed

    Hirukawa, Hirohisa

    2017-01-01

    METI/AMED are conducting a project on the development and deployment of robotic devices for nursing care to enhance the autonomy of elderly persons and assist care givers. An evaluation protocol is presented and the devices developed in the project are introduced. The devices consist of transfer assist devices (wearable/non-wearable), walking assist devices (outdoor/indoor), safety surveillance sensors (nursing home/private home), bath lift and toilet assist.

  20. Applications for alliform carbon

    DOEpatents

    Gogotsi, Yury; Mochalin, Vadym; McDonough, IV, John Kenneth; Simon, Patrice; Taberna, Pierre Louis

    2017-02-21

    This invention relates to novel applications for alliform carbon, useful in conductors and energy storage devices, including electrical double layer capacitor devices and articles incorporating such conductors and devices. Said alliform carbon particles are in the range of 2 to about 20 percent by weight, relative to the weight of the entire electrode. Said novel applications include supercapacitors and associated electrode devices, batteries, bandages and wound healing, and thin-film devices, including display devices.

  1. [Extendable Cords to Prevent Tumbling of a Suction Device during Craniotomy].

    PubMed

    Shimizu, Satoru; Mochizuki, Takahiro; Osawa, Shigeyuki; Sekiguchi, Tomoko; Koizumi, Hiroyuki; Kumabe, Toshihiro

    2016-02-01

    Suction is necessary during craniotomy, and intraoperative tumbling of the suction device interrupts operative procedures. To avoid this, we developed a technique that would fasten the device to an extendable cord as is used to secure cell phones. We used this technique in more than 300 craniotomies at the specific point of time when the suction device tends to tumble, i. e., during the opening and closure of a wound, which requires frequent instrument exchanges. Extendable cords fastened to the tip of the suction hose using a gift tie were attached to the drapes to secure the suction device next to the operative field. During the operation, the extendable cord followed the suction device manipulations. Consequently, although there was some tension in the cord during its extension, the maneuverability of the suction device was maintained. As the hanging suction device was closer to the operative field than devices stored in conventional pockets, its manipulation was easier and quicker. Upon release, the suction device automatically returned to its original position without distracting the surgeon. Tumbling of the device was prevented, and there were no procedure-related complications. Our simple modification using extendable cords prevented tumbling, avoided unnecessary replacements, and eased the manipulation of a suction device.

  2. ACTIVE DELIVERY CABLE TUNED TO DEVICE DEPLOYMENT STATE: ENHANCED VISIBILITY OF NITINOL OCCLUDERS DURING PRE-CLINICAL INTERVENTIONAL MRI

    PubMed Central

    Bell, Jamie A.; Saikus, Christina E.; Ratnayaka, Kanishka; Barbash, Israel M.; Faranesh, Anthony Z.; Franson, Dominique N.; Sonmez, Merdim; Slack, Michael C.; Lederman, Robert J.; Kocaturk, Ozgur

    2012-01-01

    Purpose To develop an active delivery system that enhances visualization of nitinol cardiac occluder devices during deployment under real-time MRI. Materials and Methods We constructed an active delivery cable incorporating a loopless antenna and a custom titanium microscrew to secure the occluder devices. The delivery cable was tuned and matched to 50Ω at 64 MHz with the occluder device attached. We used real-time balanced SSFP in a wide-bore 1.5T scanner. Device-related images were reconstructed separately and combined with surface-coil images. The delivery cable was tested in vitro in a phantom and in vivo in swine using a variety of nitinol cardiac occluder devices. Results In vitro, the active delivery cable provided little signal when the occluder device was detached and maximal signal with the device attached. In vivo, signal from the active delivery cable enabled clear visualization of occluder device during positioning and deployment. Device release resulted in decreased signal from the active cable. Post-mortem examination confirmed proper device placement. Conclusions The active delivery cable enhanced the MRI depiction of nitinol cardiac occluder devices during positioning and deployment, both in conventional and novel applications. We expect enhanced visibility to contribute to effectiveness and safety of new and emerging MRI-guided treatments. PMID:22707441

  3. Multilayer Microfluidic Devices Created From A Single Photomask

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kelly, Ryan T.; Sheen, Allison M.; Jambovane, Sachin R.

    2013-08-28

    The time and expense associated with high quality photomask production can discourage the creation of multilayer microfluidic devices, as each layer currently requires a separate photomask. Here we describe an approach in which multilayer microfabricated devices can be created from a single photomask. The separate layers and their corresponding alignment marks are arranged in separate halves of the mask for two layer devices or quadrants for four layer devices. Selective exposure of the photomask features and rotation of the device substrate between exposures result in multiple copies of the devices on each wafer. Subsequent layers are aligned to patterned featuresmore » on the substrate with the same alignment accuracy as when multiple photomasks are used. We demonstrate this approach for fabricating devices employing multilayer soft lithography (MSL) for pneumatic valving. MSL devices containing as many as 5 layers (4 aligned fluidic layers plus a manually aligned control layer) were successfully created using this approach. Device design is also modularized, enabling the presence or absence of features as well as channel heights to be selected independently from one another. The use of a single photomask to create multilayer devices results in a dramatic savings of time and/or money required to advance from device design to completed prototype.« less

  4. Progress and Design Concerns of Nanostructured Solar Energy Harvesting Devices.

    PubMed

    Leung, Siu-Fung; Zhang, Qianpeng; Tavakoli, Mohammad Mahdi; He, Jin; Mo, Xiaoliang; Fan, Zhiyong

    2016-05-01

    Integrating devices with nanostructures is considered a promising strategy to improve the performance of solar energy harvesting devices such as photovoltaic (PV) devices and photo-electrochemical (PEC) solar water splitting devices. Extensive efforts have been exerted to improve the power conversion efficiencies (PCE) of such devices by utilizing novel nanostructures to revolutionize device structural designs. The thicknesses of light absorber and material consumption can be substantially reduced because of light trapping with nanostructures. Meanwhile, the utilization of nanostructures can also result in more effective carrier collection by shortening the photogenerated carrier collection path length. Nevertheless, performance optimization of nanostructured solar energy harvesting devices requires a rational design of various aspects of the nanostructures, such as their shape, aspect ratio, periodicity, etc. Without this, the utilization of nanostructures can lead to compromised device performance as the incorporation of these structures can result in defects and additional carrier recombination. The design guidelines of solar energy harvesting devices are summarized, including thin film non-uniformity on nanostructures, surface recombination, parasitic absorption, and the importance of uniform distribution of photo-generated carriers. A systematic view of the design concerns will assist better understanding of device physics and benefit the fabrication of high performance devices in the future. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  5. Fetal heart rate monitoring device using condenser microphone sensor: Validation and comparison to standard devices.

    PubMed

    Ahmad, Husna Azyan Binti; El-Badawy, Ismail M; Singh, Om Prakash; Hisham, Rozana Binti; Malarvili, M B

    2018-04-27

    Fetal heart rate (FHR) monitoring device is highly demanded to assess the fetus health condition in home environments. Conventional standard devices such as ultrasonography and cardiotocography are expensive, bulky and uncomfortable and consequently not suitable for long-term monitoring. Herein, we report a device that can be used to measure fetal heart rate in clinical and home environments. The proposed device measures and displays the FHR on a screen liquid crystal display (LCD). The device consists of hardware that comprises condenser microphone sensor, signal conditioning, microcontroller and LCD, and software that involves the algorithm used for processing the conditioned fetal heart signal prior to FHR display. The device's performance is validated based on analysis of variance (ANOVA) test. FHR data was recorded from 22 pregnant women during the 17th to 37th week of gestation using the developed device and two standard devices; AngelSounds and Electronic Stethoscope. The results show that F-value (1.5) is less than F, (3.1) and p-value (p> 0.05). Accordingly, there is no significant difference between the mean readings of the developed and existing devices. Hence, the developed device can be used for monitoring FHR in clinical and home environments.

  6. Biofouling detection monitoring devices: status assessment. Final report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hillman, R.E.; Anson, D.; Corliss, J.M.

    1985-03-01

    An inventory of devices to detect and monitor biofouling in power plant condenser systems was prepared. The inventory was developed through a review of manufacturers' product information brochures, a general literature review, and limited personal contact with users and manufacturers. Two macrofouling and seventeen microfouling detection devices were reviewed. A summary analysis of the principal features of each device was prepared. Macrofouling devices are generally simple devices located at or near cooling water intakes. They monitor the growth of larger organisms such as mussels, barnacles, and large seaweeds. Microfouling detectors are usually located in or near the condenser tubes. Theymore » detect and monitor the growth of slime films on the tubes. Some of the devices measure changes in heat transfer or pressure drop in the condenser tubes. Other types include condenser simulators, biofilm samplers, or devices that measure the acoustic properties of the fouling films. Most devices are still in the development stage. Of the few available for general use, the type that measures heat transfer and/or pressure drop are developed to a greater degree than the other types. Recommendations for further research into development of a biofouling detection and monitoring devices include a side-by-side field comparison of selected devices, and the continued development of an effective acoustic device.« less

  7. External versus Internal Distraction Devices in Treatment of Obstructive Sleep Apnea in Craniofacial Anomalies.

    PubMed

    Rachmiel, Adi; Nseir, Saleh; Emodi, Omri; Aizenbud, Dror

    2014-07-01

    Obstructive sleep apnea is often associated with congenital craniofacial malformations due to hypoplastic mandible and decreased pharyngeal airway. In this study, we will compare external and internal distraction devices for mandibular lengthening in terms of effectiveness, results, patient comfort, and complications. Thirty-seven patients were treated by bilateral mandibular distraction osteogenesis for obstructive sleep apnea: 20 with external and 17 with internal distraction devices. Lengthening of the mandible and increase of the pharyngeal airway were obtained in all patients. Using the external devices, the average mandibular elongation was 30 mm versus 22 mm with the internal devices; however, after 1 year, the results were more stable with internal devices. External devices carried greater risk for pin tract infection than the internal devices (27.5% vs 5.88%). In addition, pin loosening in 22.5% required pin replacement or led to reduced retention period. Internal devices had a precise and predictable vector of lengthening and left less visible scars at the submandibular area but carried the disadvantage of requiring a second operation for device removal. In very young children with severe micrognathia, it was impossible to place internal devices, and external devices were used. Internal devices should be the first choice because they are more comfortable to the patients, more predictable vector of lengthening, are less vulnerable to dislodgement, and leave reduced scarring, with the great disadvantage of second operation for removal. However, external devices still should be considered mainly in severely hypoplastic cases, and the surgeon should be prepared for both options.

  8. Vibration-type particle separation device with piezoceramic vibrator

    NASA Astrophysics Data System (ADS)

    Ooe, Katsutoshi; Doi, Akihiro

    2008-12-01

    During hemanalysis, it is necessary to separate blood cells from whole blood. Many blood separation methods, for example, centrifugation and filtering, are in practical use. However, the use of these methods involves problems from the perspectives of processing speed and processing volume. We develop new types of blood separation devices that use piezo-ceramic vibrators. The first device uses a capillary. One end of the capillary is fixed to the device frame, and the other is fixed to a piezo-ceramic vibrator. The vibrator transmits bending waves to the capillary. This device can process only a small amount of solution; therefore, it is not suitable for hemanalysis. In order to solve this problem, we developed a second device; this device has a pair of thin glass plates with a small gap as a substitute for the capillary used in the first device. These devices are based on the fact that particles heavier than water move toward transverse velocity antinodes while those lighter than water move toward velocity nodes. In this report, we demonstrate the highspeed separation of silica microbeads and 50-vol% glycerol water by using these devices. The first device can separate the abovementioned solution within 3 min while the second can separate it within 1 min. Both devices are driven by a rectangular wave of 15 to 20 Vpp. Furthermore, it has been confirmed that red blood cells are separated from diluted whole blood using the first device within approximately 1 min. These devices have transparency, so they can compose as the analysis system with the chemical analyzer easily.

  9. All APAPs Are Not Equivalent for the Treatment of Sleep Disordered Breathing: A Bench Evaluation of Eleven Commercially Available Devices.

    PubMed

    Zhu, Kaixian; Roisman, Gabriel; Aouf, Sami; Escourrou, Pierre

    2015-07-15

    This study challenged on a bench-test the efficacy of auto-titrating positive airway pressure (APAP) devices for obstructive sleep disordered breathing treatment and evaluated the accuracy of the device reports. Our bench consisted of an active lung simulator and a Starling resistor. Eleven commercially available APAP devices were evaluated on their reactions to single-type SDB sequences (obstructive apnea and hypopnea, central apnea, and snoring), and to a long general breathing scenario (5.75 h) simulating various SDB during four sleep cycles and to a short scenario (95 min) simulating one sleep cycle. In the single-type sequence of 30-minute repetitive obstructive apneas, only 5 devices normalized the airflow (> 70% of baseline breathing amplitude). Similarly, normalized breathing was recorded with 8 devices only for a 20-min obstructive hypopnea sequence. Five devices increased the pressure in response to snoring. Only 4 devices maintained a constant minimum pressure when subjected to repeated central apneas with an open upper airway. In the long general breathing scenario, the pressure responses and the treatment efficacy differed among devices: only 5 devices obtained a residual obstructive AHI < 5/h. During the short general breathing scenario, only 2 devices reached the same treatment efficacy (p < 0.001), and 3 devices underestimated the AHI by > 10% (p < 0.001). The long scenario led to more consistent device reports. Large differences between APAP devices in the treatment efficacy and the accuracy of report were evidenced in the current study. © 2015 American Academy of Sleep Medicine.

  10. Improved vascularization of planar membrane diffusion devices following continuous infusion of vascular endothelial growth factor.

    PubMed

    Trivedi, N; Steil, G M; Colton, C K; Bonner-Weir, S; Weir, G C

    2000-01-01

    Improving blood vessel formation around an immunobarrier device should improve the survival of the encapsulated tissue. In the present study we investigated the formation of new blood vessels around a planar membrane diffusion device (the Baxter Theracyte System) undergoing a continuous infusion of vascular endothelial growth factor through the membranes and into the surrounding tissue. Each device (20 microl) had both an inner immunoisolation membrane and an outer vascularizing membrane. Human recombinant vascular endothelial growth factor-165 was infused at 100 ng/day (low dose: n = 6) and 500 ng/day (high dose: n = 7) for 10 days into devices implanted s.c. in Sprague-Dawley rats; noninfused devices transplanted for an identical period were used as controls (n = 5). Two days following the termination of VEGF infusion, devices were loaded with 20 microl of Lispro insulin (1 U/kg) and the kinetics of insulin release from the lumen of the device was assessed. Devices were then explanted and the number of blood vessels (capillary and noncapillary) was quantified using morphometry. High-dose vascular endothelial growth factor infusion resulted in two- to threefold more blood vessels around the device than that obtained with the noninfused devices and devices infused with low-dose vascular endothelial growth factor. This increase in the number of blood vessels was accompanied by a modest increase in insulin diffusion from the device in the high-dose vascular endothelial growth factor infusion group. We conclude that vascular endothelial growth factor can be used to improve blood vessel formation adjacent to planar membrane diffusion devices.

  11. Pacemakers and implantable cardioverter defibrillators: device longevity is more important than smaller size: the patient's viewpoint.

    PubMed

    Wild, David M; Fisher, John D; Kim, Soo G; Ferrick, Kevin J; Gross, Jay N; Palma, Eugen C

    2004-11-01

    The size of pacemakers and implantable cardioverter defibrillators (ICDs) has been diminishing progressively. If two devices are otherwise identical in components, features and technology, the one with a larger battery should have a longer service life. Therefore, patients who receive smaller devices may require more frequent surgery to replace the devices. It is uncertain whether this tradeoff for smaller size is desired by patients. We surveyed 156 patients to determine whether patients prefer a larger, longer-lasting device, or a smaller device that is less noticeable but requires more frequent surgery. The effects of subgroups were evaluated; these included body habitus, age, gender, and patients seen at time of pulse generator replacement (PGR), initial implant, or follow-up. Among 156 patients surveyed, 151 expressed a preference. Of these, 90.1% preferred the larger device and 9.9% the smaller device (P <0.0001). Among thin patients, 79.5% preferred a larger device. Ninety percent of males and 89.2% of females selected the larger device. Among younger patients (< or =72 years), 89.6% preferred the larger device, as did 90.5% of older patients (>72 years). Of patients undergoing PGR or initial implants, 95% favored the larger device, as did 86% of patients presenting for follow-up. The vast majority of patients prefer a larger device to reduce the number of potential replacement operations. This preference crosses the spectrum of those with a previously implanted device, those undergoing initial implants, those returning for routine follow-up, and patients of various ages, gender, and habitus.

  12. Recent developments of truly stretchable thin film electronic and optoelectronic devices.

    PubMed

    Zhao, Juan; Chi, Zhihe; Yang, Zhan; Chen, Xiaojie; Arnold, Michael S; Zhang, Yi; Xu, Jiarui; Chi, Zhenguo; Aldred, Matthew P

    2018-03-29

    Truly stretchable electronics, wherein all components themselves permit elastic deformation as the whole devices are stretched, exhibit unique advantages over other strategies, such as simple fabrication process, high integrity of entire components and intimate integration with curvilinear surfaces. In contrast to the stretchable devices using stretchable interconnectors to integrate with rigid active devices, truly stretchable devices are realized with or without intentionally employing structural engineering (e.g. buckling), and the whole device can be bent, twisted, or stretched to meet the demands for practical applications, which are beyond the capability of conventional flexible devices that can only bend or twist. Recently, great achievements have been made toward truly stretchable electronics. Here, the contribution of this review is an effort to provide a panoramic view of the latest progress concerning truly stretchable electronic devices, of which we give special emphasis to three kinds of thin film electronic and optoelectronic devices: (1) thin film transistors, (2) electroluminescent devices (including organic light-emitting diodes, light-emitting electrochemical cells and perovskite light-emitting diodes), and (3) photovoltaics (including organic photovoltaics and perovskite solar cells). We systematically discuss the device design and fabrication strategies, the origin of device stretchability and the relationship between the electrical and mechanical behaviors of the devices. We hope that this review provides a clear outlook of these attractive stretchable devices for a broad range of scientists and attracts more researchers to devote their time to this interesting research field in both industry and academia, thus encouraging more intelligent lifestyles for human beings in the coming future.

  13. Two simple leg net devices designed to protect lower-extremity skin grafts and donor sites and prevent decubitus ulcer.

    PubMed

    Hedman, Travis L; Chapman, Ted T; Dewey, William S; Quick, Charles D; Wolf, Steven E; Holcomb, John B

    2007-01-01

    Burn therapists routinely are tasked to position the lower extremities of burn patients for pressure ulcer prevention, skin graft protection, donor site ventilation, and edema reduction. We developed two durable and low-maintenance devices that allow effective positioning of the lower extremities. The high-profile and low-profile leg net devices were simple to fabricate and maintain. The frame was assembled using a three-quarter-inch diameter copper pipe and copper fittings (45 degrees, 90 degrees, and tees). A double layer of elasticized tubular netting was pulled over the frame and doubled back for leg support to complete the devices. The devices can be placed on any bed surface. The netting can be exchanged when soiled and the frame can be disinfected between patients using standard techniques. Both devices were used on approximately 250 patients for a total of 1200 treatment days. No incidence of pressure ulcer was observed, and graft take was not adversely affected. The devices have not required repairs or replacement. Medical providers reported they are easy to apply and effectively maintain proper positioning throughout application. Neither device interfered with the application of other positioning devices. Both devices were found to be an effective method of positioning lower extremities to prevent pressure ulcer, minimize graft loss and donor site morbidity, and reduce edema. The devices allowed for proper wound ventilation and protected grafted lower extremities on any bed surface. The devices are simple to fabricate and maintain. Both devices can be effectively used simultaneously with other positioning devices.

  14. Manufacturer evaluations of endograft modifications.

    PubMed

    Waninger, Matthew S; Whirley, Robert G; Smith, Louis J; Wolf, Ben S

    2013-03-01

    The motivation to modify the design of a vascular device can arise from a number of sources. Clinical experience with the unmodified device could suggest new design modifications to improve device performance or clinical outcomes. Similarly, clinical success with a device often suggests modifications that could broaden the applicability of the device to enable treatment of different or more advanced disease states. As a specific example, both of these scenarios have arisen during the last decade in the evolution of endovascular grafts for the treatment of abdominal aortic aneurysms, with modifications enabling the treatment of patients with shorter infrarenal necks, more angulated anatomy, and smaller access vessels. These modifications have been made by manufacturers and additionally by physicians who create branched and fenestrated devices. The experience to date with the use of fenestrated devices and the development of chimney, snorkel, and periscope techniques suggests that modifications to off-the-shelf devices may provide some clinical benefit. This experience provides additional motivation for manufacturers to develop devices to address the clinical needs not met with their current product lines. For manufacturers, the device development process includes an assessment of the new device design to determine the appropriate evaluation strategy to support the safety and effectiveness of the modified device. This report provides a high-level overview of the process generally followed by device manufacturers to evaluate a proposed device modification before market release, in accordance with local country regulations and recognized international standards such as the International Organization of Standardization (ISO) standards for endovascular grafts (ISO 25539 Part 1). Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

  15. 21 CFR 882.1560 - Skin potential measurement device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Skin potential measurement device. 882.1560 Section 882.1560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1560 Skin potential...

  16. 21 CFR 882.1620 - Intracranial pressure monitoring device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intracranial pressure monitoring device. 882.1620 Section 882.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1620 Intracranial...

  17. 21 CFR 882.1620 - Intracranial pressure monitoring device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intracranial pressure monitoring device. 882.1620 Section 882.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1620 Intracranial...

  18. 21 CFR 882.1540 - Galvanic skin response measurement device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Galvanic skin response measurement device. 882.1540 Section 882.1540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1540...

  19. 21 CFR 876.5310 - Nonimplanted, peripheral electrical continence device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nonimplanted, peripheral electrical continence device. 876.5310 Section 876.5310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876...

  20. 49 CFR 220.305 - Use of personal electronic devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.305 Use of personal electronic devices. A railroad operating employee must have each personal electronic device turned off with... 49 Transportation 4 2010-10-01 2010-10-01 false Use of personal electronic devices. 220.305...

  1. 21 CFR 870.3545 - Ventricular bypass (assist) device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

  2. Input Devices for Young Handicapped Children.

    ERIC Educational Resources Information Center

    Morris, Karen

    The versatility of the computer can be expanded considerably for young handicapped children by using input devices other than the typewriter-style keyboard. Input devices appropriate for young children can be classified into four categories: alternative keyboards, contact switches, speech input devices, and cursor control devices. Described are…

  3. 21 CFR 872.1 - Scope.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...

  4. 21 CFR 872.1 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...

  5. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in...

  6. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in...

  7. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in...

  8. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Implanted electrical urinary continence device... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in...

  9. 21 CFR 866.2900 - Microbiological specimen collection and transport device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microbiological specimen collection and transport device. 866.2900 Section 866.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  10. 21 CFR 866.2900 - Microbiological specimen collection and transport device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Microbiological specimen collection and transport device. 866.2900 Section 866.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  11. 21 CFR 866.2900 - Microbiological specimen collection and transport device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Microbiological specimen collection and transport device. 866.2900 Section 866.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  12. 21 CFR 866.2900 - Microbiological specimen collection and transport device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Microbiological specimen collection and transport device. 866.2900 Section 866.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  13. 21 CFR 866.2900 - Microbiological specimen collection and transport device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Microbiological specimen collection and transport device. 866.2900 Section 866.2900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices...

  14. 21 CFR 820.184 - Device history record.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

  15. 21 CFR 820.184 - Device history record.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

  16. 21 CFR 820.184 - Device history record.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

  17. 21 CFR 820.184 - Device history record.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

  18. 21 CFR 888.3080 - Intervertebral body fusion device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intervertebral body fusion device. 888.3080 Section 888.3080 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3080 Intervertebral body fusion...

  19. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

  20. 21 CFR 872.6570 - Impression tube.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  1. 21 CFR 890.5765 - Pressure-applying device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pressure-applying device. 890.5765 Section 890.5765 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5765 Pressure...

  2. 21 CFR 890.5765 - Presssure-applying device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Presssure-applying device. 890.5765 Section 890.5765 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5765 Presssure...

  3. 21 CFR 890.5765 - Pressure-applying device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pressure-applying device. 890.5765 Section 890.5765 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5765 Pressure...

  4. 21 CFR 890.5765 - Presssure-applying device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Presssure-applying device. 890.5765 Section 890.5765 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5765 Presssure...

  5. 21 CFR 890.5765 - Presssure-applying device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Presssure-applying device. 890.5765 Section 890.5765 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5765 Presssure...

  6. 49 CFR 220.305 - Use of personal electronic devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Use of personal electronic devices. 220.305... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.305 Use of personal electronic devices. A railroad operating employee must have each personal electronic device turned off with...

  7. 49 CFR 220.305 - Use of personal electronic devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Use of personal electronic devices. 220.305... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.305 Use of personal electronic devices. A railroad operating employee must have each personal electronic device turned off with...

  8. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used for...

  9. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used for...

  10. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used for...

  11. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used for...

  12. 21 CFR 882.5940 - Electroconvulsive therapy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Electroconvulsive therapy device. 882.5940 Section 882.5940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Electroconvulsive therapy device. (a) Identification. An electroconvulsive therapy device is a device used for...

  13. 21 CFR 820.184 - Device history record.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device history record. 820.184 Section 820.184...) MEDICAL DEVICES QUALITY SYSTEM REGULATION Records § 820.184 Device history record. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to...

  14. Computer Access. Tech Use Guide: Using Computer Technology.

    ERIC Educational Resources Information Center

    Council for Exceptional Children, Reston, VA. Center for Special Education Technology.

    One of nine brief guides for special educators on using computer technology, this guide focuses on access including adaptations in input devices, output devices, and computer interfaces. Low technology devices include "no-technology" devices (usually modifications to existing devices), simple switches, and multiple switches. High technology input…

  15. 21 CFR 870.3545 - Ventricular bypass (assist) device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ventricular bypass (assist) device. 870.3545 Section 870.3545 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3545 Ventricular...

  16. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications...

  17. 21 CFR 886.1770 - Manual refractor.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1770 Manual refractor. (a) Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

  18. 21 CFR 876.5310 - Nonimplanted, peripheral electrical continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nonimplanted, peripheral electrical continence device. 876.5310 Section 876.5310 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Therapeutic Devices § 876...

  19. 21 CFR 876.5270 - Implanted electrical urinary continence device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Implanted electrical urinary continence device. (a) Identification. An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted electrical urinary continence device...

  20. 21 CFR 864.5800 - Automated sedimentation rate device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Automated sedimentation rate device. 864.5800 Section 864.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices...

  1. 21 CFR 864.5800 - Automated sedimentation rate device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated sedimentation rate device. 864.5800 Section 864.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices...

  2. 21 CFR 864.5800 - Automated sedimentation rate device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Automated sedimentation rate device. 864.5800 Section 864.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices...

  3. 21 CFR 864.5800 - Automated sedimentation rate device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Automated sedimentation rate device. 864.5800 Section 864.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices...

  4. 21 CFR 864.5800 - Automated sedimentation rate device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Automated sedimentation rate device. 864.5800 Section 864.5800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Automated and Semi-Automated Hematology Devices...

  5. 21 CFR 870.2330 - Echocardiograph.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2330 Echocardiograph. (a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular...

  6. 21 CFR 870.2330 - Echocardiograph.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices § 870.2330 Echocardiograph. (a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular...

  7. 21 CFR 895.1 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... avoid the ban by relabeling the device for veterinary use. A device that has been banned from human use but that also has a valid veterinary use may be marketed for use as a veterinary device only under the following conditions: The device shall comply with all requirements applicable to veterinary devices under...

  8. 21 CFR 895.1 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... avoid the ban by relabeling the device for veterinary use. A device that has been banned from human use but that also has a valid veterinary use may be marketed for use as a veterinary device only under the following conditions: The device shall comply with all requirements applicable to veterinary devices under...

  9. 21 CFR 882.1570 - Powered direct-contact temperature measurement device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered direct-contact temperature measurement device. 882.1570 Section 882.1570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882...

  10. 21 CFR 882.1570 - Powered direct-contact temperature measurement device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered direct-contact temperature measurement device. 882.1570 Section 882.1570 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882...

  11. 21 CFR 882.1550 - Nerve conduction velocity measurement device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nerve conduction velocity measurement device. 882.1550 Section 882.1550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1550 Nerve...

  12. 21 CFR 882.1550 - Nerve conduction velocity measurement device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nerve conduction velocity measurement device. 882.1550 Section 882.1550 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1550 Nerve...

  13. 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3660... device are: (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical... metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a...

  14. 21 CFR 872.3670 - Resin impression tray material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3670 Resin impression tray material. (a) Identification. Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, and is used to form a...

  15. 21 CFR 806.10 - Reports of corrections and removals.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.10 Reports of corrections and removals. (a) Each device manufacturer or importer shall submit a written... injuries that have occurred with use of the device. If applicable, include the medical device report...

  16. 21 CFR 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3650... are: (1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices... metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a...

  17. 21 CFR 801.420 - Hearing aid devices; professional and patient labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Special Requirements for Specific Devices § 801.420 Hearing aid devices; professional and patient labeling. (a) Definitions for the purposes of this section... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hearing aid devices; professional and patient...

  18. 21 CFR 801.420 - Hearing aid devices; professional and patient labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Special Requirements for Specific Devices § 801.420 Hearing aid devices; professional and patient labeling. (a) Definitions for the purposes of this section... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Hearing aid devices; professional and patient...

  19. 21 CFR 872.3670 - Resin impression tray material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3670 Resin impression tray material. (a) Identification. Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, and is used to form a...

  20. 21 CFR 806.10 - Reports of corrections and removals.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Reports and Records § 806.10 Reports of corrections and removals. (a) Each device manufacturer or importer shall submit a written... injuries that have occurred with use of the device. If applicable, include the medical device report...

  1. 14 CFR 121.921 - Training devices and simulators.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... devices and simulators. (a) Each flight training device or airplane simulator that will be used in an AQP... device or flight simulator qualification level: (1) Required evaluation of individual or crew proficiency... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Training devices and simulators. 121.921...

  2. 14 CFR 121.921 - Training devices and simulators.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... devices and simulators. (a) Each flight training device or airplane simulator that will be used in an AQP... device or flight simulator qualification level: (1) Required evaluation of individual or crew proficiency... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Training devices and simulators. 121.921...

  3. 14 CFR 121.921 - Training devices and simulators.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... devices and simulators. (a) Each flight training device or airplane simulator that will be used in an AQP... device or flight simulator qualification level: (1) Required evaluation of individual or crew proficiency... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Training devices and simulators. 121.921...

  4. 14 CFR 121.921 - Training devices and simulators.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... devices and simulators. (a) Each flight training device or airplane simulator that will be used in an AQP... device or flight simulator qualification level: (1) Required evaluation of individual or crew proficiency... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Training devices and simulators. 121.921...

  5. 21 CFR 821.4 - Imported devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Imported devices. 821.4 Section 821.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE TRACKING REQUIREMENTS General Provisions § 821.4 Imported devices. For purposes of this...

  6. 21 CFR 821.4 - Imported devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Imported devices. 821.4 Section 821.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE TRACKING REQUIREMENTS General Provisions § 821.4 Imported devices. For purposes of this...

  7. 49 CFR 220.303 - General use of electronic devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.303 General use of electronic devices. A railroad operating employee shall not use an electronic device if that use would... 49 Transportation 4 2010-10-01 2010-10-01 false General use of electronic devices. 220.303 Section...

  8. 40 CFR 60.343 - Monitoring of emissions and operations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... device for the continuous measurement of the pressure loss of the gas stream through the scrubber. The monitoring device must be accurate within ±250 pascals (one inch of water). (2) A monitoring device for continuous measurement of the scrubbing liquid supply pressure to the control device. The monitoring device...

  9. 21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...

  10. 21 CFR 862.1675 - Blood specimen collection device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood specimen collection device. 862.1675 Section... Systems § 862.1675 Blood specimen collection device. (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate...

  11. 28 CFR 3.5 - Forfeiture of gambling devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Forfeiture of gambling devices. 3.5 Section 3.5 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.5 Forfeiture of gambling devices. For purposes of seizure and forfeiture of gambling devices see section 8 of this chapter. [Order...

  12. 28 CFR 3.5 - Forfeiture of gambling devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 1 2011-07-01 2011-07-01 false Forfeiture of gambling devices. 3.5 Section 3.5 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.5 Forfeiture of gambling devices. For purposes of seizure and forfeiture of gambling devices see section 8 of this chapter. [Order...

  13. 21 CFR 820.181 - Device master record.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

  14. 21 CFR 820.181 - Device master record.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device master record. 820.181 Section 820.181 Food... DEVICES QUALITY SYSTEM REGULATION Records § 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in...

  15. 5 CFR 1201.52 - Public hearings.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... Any objections to the order will be made a part of the record. (b) Electronic devices. Absent express... room; all cell phones, text devices, and all other two-way communications devices shall be powered off in the hearing room. Further, no cameras, recording devices, and/or transmitting devices may be...

  16. 5 CFR 1201.52 - Public hearings.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... Any objections to the order will be made a part of the record. (b) Electronic devices. Absent express... room; all cell phones, text devices, and all other two-way communications devices shall be powered off in the hearing room. Further, no cameras, recording devices, and/or transmitting devices may be...

  17. 21 CFR 862.1675 - Blood specimen collection device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood specimen collection device. 862.1675 Section... Systems § 862.1675 Blood specimen collection device. (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate...

  18. 21 CFR 862.1675 - Blood specimen collection device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood specimen collection device. 862.1675 Section... Systems § 862.1675 Blood specimen collection device. (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate...

  19. 21 CFR 862.1675 - Blood specimen collection device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood specimen collection device. 862.1675 Section... Systems § 862.1675 Blood specimen collection device. (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate...

  20. 21 CFR 862.1675 - Blood specimen collection device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood specimen collection device. 862.1675 Section... Systems § 862.1675 Blood specimen collection device. (a) Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate...

  1. 28 CFR 3.5 - Forfeiture of gambling devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Forfeiture of gambling devices. 3.5 Section 3.5 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.5 Forfeiture of gambling devices. For purposes of seizure and forfeiture of gambling devices see section 8 of this chapter. [Order...

  2. 28 CFR 3.5 - Forfeiture of gambling devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 1 2012-07-01 2012-07-01 false Forfeiture of gambling devices. 3.5 Section 3.5 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.5 Forfeiture of gambling devices. For purposes of seizure and forfeiture of gambling devices see section 8 of this chapter. [Order...

  3. 28 CFR 3.5 - Forfeiture of gambling devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Forfeiture of gambling devices. 3.5 Section 3.5 Judicial Administration DEPARTMENT OF JUSTICE GAMBLING DEVICES § 3.5 Forfeiture of gambling devices. For purposes of seizure and forfeiture of gambling devices see section 8 of this chapter. [Order...

  4. 21 CFR 876.5320 - Nonimplanted electrical continence device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nonimplanted electrical continence device. 876... Nonimplanted electrical continence device. (a) Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical...

  5. 21 CFR 876.5320 - Nonimplanted electrical continence device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonimplanted electrical continence device. 876... Nonimplanted electrical continence device. (a) Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical...

  6. 21 CFR 876.5320 - Nonimplanted electrical continence device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nonimplanted electrical continence device. 876... Nonimplanted electrical continence device. (a) Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical...

  7. 21 CFR 876.5320 - Nonimplanted electrical continence device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nonimplanted electrical continence device. 876... Nonimplanted electrical continence device. (a) Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical...

  8. 21 CFR 866.2500 - Microtiter diluting and dispensing device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Microtiter diluting and dispensing device. 866.2500 Section 866.2500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2500...

  9. 21 CFR 866.2500 - Microtiter diluting and dispensing device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Microtiter diluting and dispensing device. 866.2500 Section 866.2500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2500...

  10. 21 CFR 866.2440 - Automated medium dispensing and stacking device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Automated medium dispensing and stacking device. 866.2440 Section 866.2440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2440...

  11. 21 CFR 866.2500 - Microtiter diluting and dispensing device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Microtiter diluting and dispensing device. 866.2500 Section 866.2500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2500...

  12. 21 CFR 866.2440 - Automated medium dispensing and stacking device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Automated medium dispensing and stacking device. 866.2440 Section 866.2440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2440...

  13. 77 FR 16126 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    .... FDA-2012-N-0159] Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for... convened a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (Microbiology Devices Panel) on June 29, 2011 (Ref. 2). Although not a formal reclassification meeting, panel...

  14. 21 CFR 866.2500 - Microtiter diluting and dispensing device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Microtiter diluting and dispensing device. 866.2500 Section 866.2500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2500...

  15. 21 CFR 866.2500 - Microtiter diluting and dispensing device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Microtiter diluting and dispensing device. 866.2500 Section 866.2500 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2500...

  16. 21 CFR 866.2440 - Automated medium dispensing and stacking device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Automated medium dispensing and stacking device. 866.2440 Section 866.2440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2440...

  17. 21 CFR 866.2440 - Automated medium dispensing and stacking device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated medium dispensing and stacking device. 866.2440 Section 866.2440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2440...

  18. 21 CFR 866.2440 - Automated medium dispensing and stacking device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Automated medium dispensing and stacking device. 866.2440 Section 866.2440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Microbiology Devices § 866.2440...

  19. Mobile Device Usage in Higher Education

    ERIC Educational Resources Information Center

    Delcker, Jan; Honal, Andrea; Ifenthaler, Dirk

    2016-01-01

    This paper focuses on mobile device usage of students in higher education. While more and more students embrace mobile devices in their daily life, institutions attempt to profit from those devices for educational purposes. It is therefore crucial for institutional development to identify students' needs and how mobile devices may facilitate these…

  20. 21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electrosurgical cutting and coagulation device and....4400 Electrosurgical cutting and coagulation device and accessories. (a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control...

  1. 21 CFR 895.25 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... eliminated by labeling or a change in labeling, or change in advertising if the device is a restricted device... person(s) responsible for the labeling or advertising of the device specifying: (1) The deception or risk... labeling, or change in advertising if the device is a restricted device, necessary to correct the deception...

  2. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...

  3. 75 FR 44172 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... document proposed to amend certain neurological and physical medicine device regulations to establish... to amend certain neurological device and physical medicine device regulations to establish special...

  4. 21 CFR 890.5050 - Daily activity assist device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

  5. 21 CFR 890.5050 - Daily activity assist device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

  6. 21 CFR 890.5050 - Daily activity assist device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

  7. 21 CFR 890.5575 - Powered external limb overload warning device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered external limb overload warning device. 890.5575 Section 890.5575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890...

  8. 21 CFR 890.5575 - Powered external limb overload warning device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered external limb overload warning device. 890.5575 Section 890.5575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890...

  9. 21 CFR 890.5575 - Powered external limb overload warning device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered external limb overload warning device. 890.5575 Section 890.5575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890...

  10. 21 CFR 890.5050 - Daily activity assist device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

  11. 21 CFR 890.5575 - Powered external limb overload warning device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered external limb overload warning device. 890.5575 Section 890.5575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890...

  12. 21 CFR 890.5050 - Daily activity assist device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Daily activity assist device. 890.5050 Section 890.5050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890.5050 Daily activity...

  13. 21 CFR 890.5575 - Powered external limb overload warning device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered external limb overload warning device. 890.5575 Section 890.5575 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Therapeutic Devices § 890...

  14. 49 CFR 220.303 - General use of electronic devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false General use of electronic devices. 220.303 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.303 General use of electronic devices. A railroad operating employee shall not use an electronic device if that use would...

  15. 49 CFR 220.303 - General use of electronic devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false General use of electronic devices. 220.303 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Electronic Devices § 220.303 General use of electronic devices. A railroad operating employee shall not use an electronic device if that use would...

  16. 30 CFR 27.23 - Automatic warning device.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Automatic warning device. 27.23 Section 27.23... Automatic warning device. (a) An automatic warning device shall be suitably constructed for incorporation in... automatic warning device shall include an alarm signal (audible or colored light), which shall be made to...

  17. 30 CFR 27.23 - Automatic warning device.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Automatic warning device. 27.23 Section 27.23... Automatic warning device. (a) An automatic warning device shall be suitably constructed for incorporation in... automatic warning device shall include an alarm signal (audible or colored light), which shall be made to...

  18. 30 CFR 27.23 - Automatic warning device.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Automatic warning device. 27.23 Section 27.23... Automatic warning device. (a) An automatic warning device shall be suitably constructed for incorporation in... automatic warning device shall include an alarm signal (audible or colored light), which shall be made to...

  19. 30 CFR 27.23 - Automatic warning device.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Automatic warning device. 27.23 Section 27.23... Automatic warning device. (a) An automatic warning device shall be suitably constructed for incorporation in... automatic warning device shall include an alarm signal (audible or colored light), which shall be made to...

  20. 33 CFR 154.525 - Monitoring devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Monitoring devices. 154.525... Monitoring devices. The COTP may require the facility to install monitoring devices if the installation of monitoring devices at the facility would significantly limit the size of a discharge of oil or hazardous...

  1. 21 CFR 886.4270 - Intraocular gas.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4270 Intraocular gas. (a) Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure... required. As of May 28, 1976, an approval under section 515 of the act is required before this device may...

  2. 21 CFR 886.5844 - Prescription spectacle lens.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... for the patient. The device may be modified to protect the eyes from bright sunlight (i.e...) MEDICAL DEVICES OPHTHALMIC DEVICES Therapeutic Devices § 886.5844 Prescription spectacle lens. (a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by...

  3. 21 CFR 886.4300 - Intraocular lens guide.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct... lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  4. 21 CFR 886.1500 - Headband mirror.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1500 Headband mirror. (a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

  5. 21 CFR 886.1390 - Flexible diagnostic Fresnel lens.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1390 Flexible diagnostic Fresnel lens. (a) Identification. A flexible diagnostic Fresnel lens is a device that is a very thin lens which has its surface a concentric series of increasingly refractive zones. The device is intended to be applied...

  6. 40 CFR 60.2141 - By what date must I conduct the initial air pollution control device inspection?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... air pollution control device inspection? 60.2141 Section 60.2141 Protection of Environment... initial air pollution control device inspection? (a) The initial air pollution control device inspection... startup. (b) Within 10 operating days following an air pollution control device inspection, all necessary...

  7. 40 CFR 60.2141 - By what date must I conduct the initial air pollution control device inspection?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... air pollution control device inspection? 60.2141 Section 60.2141 Protection of Environment... initial air pollution control device inspection? (a) The initial air pollution control device inspection... startup. (b) Within 10 operating days following an air pollution control device inspection, all necessary...

  8. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Suction Apparatus Device Intended for Negative Pressure Wound Therapy AGENCY: Food and Drug Administration...- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II... ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative...

  9. Early Detection of Prostate Cancer

    DTIC Science & Technology

    2007-01-01

    pads and the external traces. Figure 13 shows the copper board with SMA connectors which were used to test the SH-SAW devices. The frequency...Figure 11. 3-dimensional view of the final device. Figure 12. Fabricated SH-SAW devices cut on blue tape. Figure 13. SH-SAW devices on copper board...Figure 12. Fabricated SH-SAW devices cut on blue tape. 46 Figure 13. SH-SAW devices on copper board with SMA connectors. 47 Figure 14

  10. Unitary lens semiconductor device

    DOEpatents

    Lear, Kevin L.

    1997-01-01

    A unitary lens semiconductor device and method. The unitary lens semiconductor device is provided with at least one semiconductor layer having a composition varying in the growth direction for unitarily forming one or more lenses in the semiconductor layer. Unitary lens semiconductor devices may be formed as light-processing devices such as microlenses, and as light-active devices such as light-emitting diodes, photodetectors, resonant-cavity light-emitting diodes, vertical-cavity surface-emitting lasers, and resonant cavity photodetectors.

  11. Theoretical and material studies on thin-film electroluminescent devices

    NASA Technical Reports Server (NTRS)

    Summers, C. J.; Brennan, K. F.

    1986-01-01

    Electroluminescent materials and device technology were assessed. The evaluation strongly suggests the need for a comprehensive theoretical and experimental study of both materials and device structures, particularly in the following areas: carrier generation and multiplication; radiative and nonradiative processes of luminescent centers; device modeling; new device concepts; and single crystal materials growth and characterization. Modeling of transport properties of hot electrons in ZnSe and the generation of device concepts were initiated.

  12. Imposed Power of Breathing Associated With Use of an Impedance Threshold Device

    DTIC Science & Technology

    2007-02-01

    threshold device and a sham impedance threshold device. DESIGN: Prospective randomized blinded protocol. SETTING: University medical center. PATIENTS...for males). METHODS: The volunteers completed 2 trials of breathing through a face mask fitted with an active impedance threshold device set to open...at -7cmH 2 O pressure, or with a sham impedance threshold device, which was identical to the active device except that it did not contain an

  13. Portable apparatus for separating sample and detecting target analytes

    DOEpatents

    Renzi, Ronald F.; Wally, Karl; Crocker, Robert W.; Stamps, James F.; Griffiths; Stewart K. ,; Fruetel, Julia A.; Horn, Brent A.; Shokair, Isaac R.; Yee, Daniel D.; VanderNoot, Victoria A.; Wiedenman, Boyd J.; West, Jason A. A.; Ferko, Scott M.

    2008-11-18

    Portable devices and methods for determining the presence of a target analyte using a portable device are provided. The portable device is preferably hand-held. A sample is injected to the portable device. A microfluidic separation is performed within the portable device and at least one separated component detected by a detection module within the portable device, in embodiments of the invention. A target analyte is identified, based on the separated component, and the presence of the target analyte is indicated on an output interface of the portable device, in accordance with embodiments of the invention.

  14. Learning from adverse incidents involving medical devices.

    PubMed

    Amoore, John; Ingram, Paula

    While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medical devices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms.

  15. Optical signal splitting and chirping device modeling

    NASA Astrophysics Data System (ADS)

    Vinogradova, Irina L.; Andrianova, Anna V.; Meshkov, Ivan K.; Sultanov, Albert Kh.; Abdrakhmanova, Guzel I.; Grakhova, Elizaveta P.; Ishmyarov, Arsen A.; Yantilina, Liliya Z.; Kutlieva, Gulnaz R.

    2017-04-01

    This article examines the devices for optical signal splitting and chirping device modeling. Models with splitting and switching functions are taken into consideration. The described device for optical signal splitting and chirping represents interferential splitter with profiled mixer which provides allocation of correspondent spectral component from ultra wide band frequency diapason, and signal phase shift for aerial array (AA) directive diagram control. This paper proposes modeling for two types of devices for optical signal splitting and chirping: the interference-type optical signal splitting and chirping device and the long-distance-type optical signal splitting and chirping device.

  16. Packaging of solid state devices

    DOEpatents

    Glidden, Steven C.; Sanders, Howard D.

    2006-01-03

    A package for one or more solid state devices in a single module that allows for operation at high voltage, high current, or both high voltage and high current. Low thermal resistance between the solid state devices and an exterior of the package and matched coefficient of thermal expansion between the solid state devices and the materials used in packaging enables high power operation. The solid state devices are soldered between two layers of ceramic with metal traces that interconnect the devices and external contacts. This approach provides a simple method for assembling and encapsulating high power solid state devices.

  17. Systems and methods to reduce reductant consumption in exhaust aftertreament systems

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gupta, Aniket; Cunningham, Michael J.

    Systems, apparatus and methods are provided for reducing reductant consumption in an exhaust aftertreatment system that includes a first SCR device and a downstream second SCR device, a first reductant injector upstream of the first SCR device, and a second reductant injector between the first and second SCR devices. NOx conversion occurs with reductant injection by the first reductant injector to the first SCR device in a first temperature range and with reductant injection by the second reductant injector to the second SCR device when the temperature of the first SCR device is above a reductant oxidation conversion threshold.

  18. Underwater Sound Levels at a Wave Energy Device Testing Facility in Falmouth Bay, UK.

    PubMed

    Garrett, Joanne K; Witt, Matthew J; Johanning, Lars

    2016-01-01

    Passive acoustic monitoring devices were deployed at FaBTest in Falmouth Bay, UK, a marine renewable energy device testing facility during trials of a wave energy device. The area supports considerable commercial shipping and recreational boating along with diverse marine fauna. Noise monitoring occurred during (1) a baseline period, (2) installation activity, (3) the device in situ with inactive power status, and (4) the device in situ with active power status. This paper discusses the preliminary findings of the sound recording at FabTest during these different activity periods of a wave energy device trial.

  19. Recent progress on fabrication of memristor and transistor-based neuromorphic devices for high signal processing speed with low power consumption

    NASA Astrophysics Data System (ADS)

    Hadiyawarman; Budiman, Faisal; Goldianto Octensi Hernowo, Detiza; Pandey, Reetu Raj; Tanaka, Hirofumi

    2018-03-01

    The advanced progress of electronic-based devices for artificial neural networks and recent trends in neuromorphic engineering are discussed in this review. Recent studies indicate that the memristor and transistor are two types of devices that can be implemented as neuromorphic devices. The electrical switching characteristics and physical mechanism of neuromorphic devices based on metal oxide, metal sulfide, silicon, and carbon materials are broadly covered in this review. Moreover, the switching performance comparison of several materials mentioned above are well highlighted, which would be useful for the further development of memristive devices. Recent progress in synaptic devices and the application of a switching device in the learning process is also discussed in this paper.

  20. Cybersecurity for Connected Diabetes Devices

    PubMed Central

    Klonoff, David C.

    2015-01-01

    Diabetes devices are increasingly connected wirelessly to each other and to data-displaying reader devices. Threats to the accurate flow of information and commands may compromise the function of these devices and put their users at risk of health complications. Sound cybersecurity of connected diabetes devices is necessary to maintain confidentiality, integrity, and availability of the data and commands. Diabetes devices can be hacked by unauthorized agents and also by patients themselves to extract data that are not automatically provided by product software. Unauthorized access to connected diabetes devices has been simulated and could happen in reality. A cybersecurity standard designed specifically for connected diabetes devices will improve the safety of these products and increase confidence of users that the products will be secure. PMID:25883162

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