Evolution and update on current devices for prosthetic breast reconstruction

PubMed Central

2015-01-01

Over the past decade, the leading breast reconstruction modality has shifted from autologous tissue to implants. This trend reversal is multi-factorial but includes increasing bilateral mastectomies and the more widespread acceptance of implants due to stringent quality and safety regulatory surveillance by the US Food and Drug Administration (FDA). Since 2012, the US FDA has approved several new implant styles, shapes and textures, increasing the choices for patients and surgeons. Predictable, superior aesthetic results after prosthetic breast reconstruction are attainable, but require thoughtful planning, precise surgical technique and appropriate device selection based on several different patient and surgeon parameters, such as patient desires, body mass index, breast shape, mastectomy flap quality and tissue based bio-dimensional assessment. This article briefly reviews historic devices used in prosthetic breast reconstruction beginning in the 1960s through the modern generation devices used today. We reflect on the rigorous hurdles endured over the last several decades leading to the approval of silicone gel devices, along with their well-established safety and efficacy. The various implant characteristics can affect feel and performance of the device. The many different styles and features of implants and expanders are described emphasizing surgical indications, advantages and disadvantages of each device. PMID:26005642

Osseointegrated Implant Applications in Cosmetic and Functional Skull Base Rehabilitation

PubMed Central

Benscoter, Brent J.; Jaber, James J.; Kircher, Matthew L.; Marzo, Sam J.; Leonetti, John P.

2011-01-01

This study discusses the indications, outcomes, and complications in patients that underwent osseointegrated implantation for skull base rehabilitation. We conducted a retrospective review of eight patients with skull base defects who had undergone implantation of a facial prosthetic retention device ± bone-anchored hearing aid at a tertiary academic referral center. Descriptive analysis of applications, techniques, outcomes, and complications were reviewed. The majority of patients were males (n = 6) with previously diagnosed skull base malignancy (n = 5) with an average age of 46 (range, 14 to 77). All patients received an implanted facial prosthetic device either for an aural (n = 7) or orbital (n = 1) prosthesis. There were only two complications that included infection (n = 1) and implant extrusion (n = 1). Osseointegrated implantation of abutments for anchoring prosthetic devices in patients for skull base rehabilitation provides an excellent cosmetic option with minimal complications. PMID:22451830

Corynebacterium minutissimum vascular graft infection: case report and review of 281 cases of prosthetic device-related Corynebacterium infection.

PubMed

Reece, Rebecca M; Cunha, Cheston B; Rich, Josiah D

2014-09-01

Corynebacterium spp. have proven their pathogenic potential in causing infections, particularly in the setting of immunosuppression and prosthetic devices. We conducted a PubMed literature review of all cases of Corynebacterium prosthetic device infections published in the English language through December 2013. The majority of cases involved peritoneal dialysis and central venous catheters, but prosthetic joints and central nervous system shunts/drains were also involved. The management of these cases in terms of retention or removal of the device was not uniform; however, the overall mortality remained the same among both groups. All of these prosthetic device infections pose potential problems in management when the device cannot be removed safely for the patient, especially with the lack of data on the pathogenicity of Corynebacterium species. However with better identification of species and sensitivities, successful treatment is possible even with retention of the device.

21 CFR 890.3420 - External limb prosthetic component.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External limb prosthetic component. 890.3420 Section 890.3420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3420...

21 CFR 890.3025 - Prosthetic and orthotic accessory.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prosthetic and orthotic accessory. 890.3025 Section 890.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3025...

21 CFR 890.3025 - Prosthetic and orthotic accessory.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prosthetic and orthotic accessory. 890.3025 Section 890.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3025...

21 CFR 890.3025 - Prosthetic and orthotic accessory.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prosthetic and orthotic accessory. 890.3025 Section 890.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3025...

21 CFR 890.3420 - External limb prosthetic component.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External limb prosthetic component. 890.3420 Section 890.3420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3420...

21 CFR 890.3420 - External limb prosthetic component.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External limb prosthetic component. 890.3420 Section 890.3420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3420...

21 CFR 890.3025 - Prosthetic and orthotic accessory.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic and orthotic accessory. 890.3025 Section 890.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3025...

21 CFR 890.3420 - External limb prosthetic component.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External limb prosthetic component. 890.3420 Section 890.3420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3420...

21 CFR 890.3420 - External limb prosthetic component.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External limb prosthetic component. 890.3420 Section 890.3420 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3420...

21 CFR 890.3025 - Prosthetic and orthotic accessory.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prosthetic and orthotic accessory. 890.3025 Section 890.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3025...

Rehabilitation regimes based upon psychophysical studies of prosthetic vision

NASA Astrophysics Data System (ADS)

Chen, S. C.; Suaning, G. J.; Morley, J. W.; Lovell, N. H.

2009-06-01

Human trials of prototype visual prostheses have successfully elicited visual percepts (phosphenes) in the visual field of implant recipients blinded through retinitis pigmentosa and age-related macular degeneration. Researchers are progressing rapidly towards a device that utilizes individual phosphenes as the elementary building blocks to compose a visual scene. This form of prosthetic vision is expected, in the near term, to have low resolution, large inter-phosphene gaps, distorted spatial distribution of phosphenes, restricted field of view, an eccentrically located phosphene field and limited number of expressible luminance levels. In order to fully realize the potential of these devices, there needs to be a training and rehabilitation program which aims to assist the prosthesis recipients to understand what they are seeing, and also to adapt their viewing habits to optimize the performance of the device. Based on the literature of psychophysical studies in simulated and real prosthetic vision, this paper proposes a comprehensive, theoretical training regime for a prosthesis recipient: visual search, visual acuity, reading, face/object recognition, hand-eye coordination and navigation. The aim of these tasks is to train the recipients to conduct visual scanning, eccentric viewing and reading, discerning low-contrast visual information, and coordinating bodily actions for visual-guided tasks under prosthetic vision. These skills have been identified as playing an important role in making prosthetic vision functional for the daily activities of their recipients.

Prosthetic Tool For Holding Small Ferromagnetic Parts

NASA Technical Reports Server (NTRS)

Norton, William E.; Carden, James R.; Belcher, Jewell G., Jr.; Vest, Thomas W.

1995-01-01

Tool attached to prosthetic hand or arm enables user to hold nails, screws, nuts, rivets, and other small ferromagnetic objects on small magnetic tip. Device adjusted to hold nail or screw at proper angle for hammering or for use of screwdriver, respectively. Includes base connector with threaded outer surface and lower male member inserted in standard spring-action, quick-connect/quick-disconnect wrist adapter on prosthetic hand or arm.

ARM-based visual processing system for prosthetic vision.

PubMed

Matteucci, Paul B; Byrnes-Preston, Philip; Chen, Spencer C; Lovell, Nigel H; Suaning, Gregg J

2011-01-01

A growing number of prosthetic devices have been shown to provide visual perception to the profoundly blind through electrical neural stimulation. These first-generation devices offer promising outcomes to those affected by degenerative disorders such as retinitis pigmentosa. Although prosthetic approaches vary in their placement of the stimulating array (visual cortex, optic-nerve, epi-retinal surface, sub-retinal surface, supra-choroidal space, etc.), most of the solutions incorporate an externally-worn device to acquire and process video to provide the implant with instructions on how to deliver electrical stimulation to the patient, in order to elicit phosphenized vision. With the significant increase in availability and performance of low power-consumption smart phone and personal device processors, the authors investigated the use of a commercially available ARM (Advanced RISC Machine) device as an externally-worn processing unit for a prosthetic neural stimulator for the retina. A 400 MHz Samsung S3C2440A ARM920T single-board computer was programmed to extract 98 values from a 1.3 Megapixel OV9650 CMOS camera using impulse, regional averaging and Gaussian sampling algorithms. Power consumption and speed of video processing were compared to results obtained to similar reported devices. The results show that by using code optimization, the system is capable of driving a 98 channel implantable device for the restoration of visual percepts to the blind.

Advanced upper limb prosthetic devices: implications for upper limb prosthetic rehabilitation.

PubMed

Resnik, Linda; Meucci, Marissa R; Lieberman-Klinger, Shana; Fantini, Christopher; Kelty, Debra L; Disla, Roxanne; Sasson, Nicole

2012-04-01

The number of catastrophic injuries caused by improvised explosive devices in the Afghanistan and Iraq Wars has increased public, legislative, and research attention to upper limb amputation. The Department of Veterans Affairs (VA) has partnered with the Defense Advanced Research Projects Agency and DEKA Integrated Solutions to optimize the function of an advanced prosthetic arm system that will enable greater independence and function. In this special communication, we examine current practices in prosthetic rehabilitation including trends in adoption and use of prosthetic devices, financial considerations, and the role of rehabilitation team members in light of our experiences with a prototype advanced upper limb prosthesis during a VA study to optimize the device. We discuss key challenges in the adoption of advanced prosthetic technology and make recommendations for service provision and use of advanced upper limb prosthetics. Rates of prosthetic rejection are high among upper limb amputees. However, these rates may be reduced with sufficient training by a highly specialized, multidisciplinary team of clinicians, and a focus on patient education and empowerment throughout the rehabilitation process. There are significant challenges emerging that are unique to implementing the use of advanced upper limb prosthetic technology, and a lack of evidence to establish clinical guidelines regarding prosthetic prescription and treatment. Finally, we make recommendations for future research to aid in the identification of best practices and development of policy decisions regarding insurance coverage of prosthetic rehabilitation. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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...

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...

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.

An extremely lightweight fingernail worn prosthetic interface device

NASA Astrophysics Data System (ADS)

Yetkin, Oguz; Ahluwalia, Simranjit; Silva, Dinithi; Kasi-Okonye, Isioma; Volker, Rachael; Baptist, Joshua R.; Popa, Dan O.

2016-05-01

Upper limb prosthetics are currently operated using several electromyography sensors mounted on an amputee's residual limb. In order for any prosthetic driving interface to be widely adopted, it needs to be responsive, lightweight, and out of the way when not being used. In this paper we discuss the possibility of replacing such electrodes with fingernail optical sensor systems mounted on the sound limb. We present a prototype device that can detect pinch gestures and communicate with the prosthetic system. The device detects the relative position of fingers to each other by measuring light transmitted via tissue. Applications are not limited to prosthetic control, but can be extended to other human-machine interfaces.

User surveys support designing a prosthetic wrist that incorporates the Dart Thrower's Motion.

PubMed

Davidson, Matthew; Bodine, Cathy; Weir, Richard F Ff

2018-03-07

Prosthetic devices are not meeting the needs of people with upper limb amputations. Due to controlsidelimitations, prosthetic wrists cannot yet be fully articulated. This study sought to determine which wrist motions users felt were most important for completing activities of daily living. We specifically invstigated whether adding a combinationof flexion and deviation known as the Dart Thrower's Motion to a prosthetic wrist would help improve functionality. Fifteen participants with a trans-radial amputation, aged 25-64 years, who use a prosthesis completed an online survey and answered interview questions to determine which types of tasks pose particular challenges. Participants were asked what kinds of improvements they would like to see in a new prosthesis. A subset of five participants were interviewed in-depth to provide further information about difficulties they face using their device. The survey showed that participants had difficulty performing activities of daily living that involve a combination of wrist flexion and deviation known as the "Dart Throwers Motion". Interview responses confirmed that users have difficulty performing these tasks, especially those that require tools. Additionally, users said that they were more interested in having flexion and deviation than rotation in a prosthetic wrist. This research indicates that including the Dart Thrower's Motion in future designs of prosthetic wrists would improve these devices and people with upper limb amputations would be excited to see this improvement in their devices. Implications for Rehabilitation • Over one third of people with upper limb amputations do not use a prosthesis because prosthetic devices do not meet their needs.• The number of motions possible in state of the art prosthetic devices is limited by the small number of control sites available.• The Dart Thrower?s Motion is a wrist motion used for many activities of daily living but unavailable in commercial prosthetics leading many prosthetics users to have difficulty with these tasks.• Prosthetic use, and therefore quality of life, could be improved by including the Dart Thrower's Motion in a prosthesis.

Beyond intuitive anthropomorphic control: recent achievements using brain computer interface technologies

NASA Astrophysics Data System (ADS)

Pohlmeyer, Eric A.; Fifer, Matthew; Rich, Matthew; Pino, Johnathan; Wester, Brock; Johannes, Matthew; Dohopolski, Chris; Helder, John; D'Angelo, Denise; Beaty, James; Bensmaia, Sliman; McLoughlin, Michael; Tenore, Francesco

2017-05-01

Brain-computer interface (BCI) research has progressed rapidly, with BCIs shifting from animal tests to human demonstrations of controlling computer cursors and even advanced prosthetic limbs, the latter having been the goal of the Revolutionizing Prosthetics (RP) program. These achievements now include direct electrical intracortical microstimulation (ICMS) of the brain to provide human BCI users feedback information from the sensors of prosthetic limbs. These successes raise the question of how well people would be able to use BCIs to interact with systems that are not based directly on the body (e.g., prosthetic arms), and how well BCI users could interpret ICMS information from such devices. If paralyzed individuals could use BCIs to effectively interact with such non-anthropomorphic systems, it would offer them numerous new opportunities to control novel assistive devices. Here we explore how well a participant with tetraplegia can detect infrared (IR) sources in the environment using a prosthetic arm mounted camera that encodes IR information via ICMS. We also investigate how well a BCI user could transition from controlling a BCI based on prosthetic arm movements to controlling a flight simulator, a system with different physical dynamics than the arm. In that test, the BCI participant used environmental information encoded via ICMS to identify which of several upcoming flight routes was the best option. For both tasks, the BCI user was able to quickly learn how to interpret the ICMSprovided information to achieve the task goals.

21 CFR 870.3935 - Prosthetic heart valve holder.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prosthetic heart valve holder. 870.3935 Section... heart valve holder. (a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place. (b) Classification. Class I. The device is...

21 CFR 870.3935 - Prosthetic heart valve holder.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prosthetic heart valve holder. 870.3935 Section... heart valve holder. (a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place. (b) Classification. Class I. The device is...

21 CFR 870.3935 - Prosthetic heart valve holder.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthetic heart valve holder. 870.3935 Section... heart valve holder. (a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place. (b) Classification. Class I. The device is...

21 CFR 870.3935 - Prosthetic heart valve holder.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prosthetic heart valve holder. 870.3935 Section... heart valve holder. (a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place. (b) Classification. Class I. The device is...

21 CFR 870.3935 - Prosthetic heart valve holder.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prosthetic heart valve holder. 870.3935 Section... heart valve holder. (a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place. (b) Classification. Class I. The device is...

Performance of Optimized Prosthetic Ankle Designs That Are Based on a Hydraulic Variable Displacement Actuator (VDA).

PubMed

Gardiner, James; Bari, Abu Zeeshan; Kenney, Laurence; Twiste, Martin; Moser, David; Zahedi, Saeed; Howard, David

2017-12-01

Current energy storage and return prosthetic feet only marginally reduce the cost of amputee locomotion compared with basic solid ankle cushioned heel feet, possibly due to their lack of push-off at the end of stance. To the best of our knowledge, a prosthetic ankle that utilizes a hydraulic variable displacement actuator (VDA) to improve push-off performance has not previously been proposed. Therefore, here we report a design optimization and simulation feasibility study for a VDA-based prosthetic ankle. The proposed device stores the eccentric ankle work done from heel strike to maximum dorsiflexion in a hydraulic accumulator and then returns the stored energy to power push-off. Optimization was used to establish the best spring characteristic and gear ratio between ankle and VDA. The corresponding simulations show that, in level walking, normal push-off is achieved and, per gait cycle, the energy stored in the accumulator increases by 22% of the requirements for normal push-off. Although the results are promising, there are many unanswered questions and, for this approach to be a success, a new miniature, low-losses, and lightweight VDA would be required that is half the size of the smallest commercially available device.

Cochlear Implant Using Neural Prosthetics

NASA Astrophysics Data System (ADS)

Gupta, Shweta; Singh, Shashi kumar; Dubey, Pratik Kumar

2012-10-01

This research is based on neural prosthetic device. The oldest and most widely used of these electrical, and often computerized, devices is the cochlear implant, which has provided hearing to thousands of congenitally deaf people in this country. Recently, the use of the cochlear implant is expanding to the elderly, who frequently suffer major hearing loss. More cutting edge are artificial retinas, which are helping dozens of blind people see, and ìsmartî artificial arms and legs that amputees can maneuver by thoughts alone, and that feel more like real limbs.Research, which curiosity led to explore frog legs dancing during thunderstorms, a snail shapedorgan in the inner ear, and how various eye cells react to light, have fostered an understanding of how to ìtalkî to the nervous system. That understanding combined with the miniaturization of electronics and enhanced computer processing has enabled prosthetic devices that often can bridge the gap in nerve signaling that is caused by disease or injury.

Identifying the values and preferences of prosthetic users: a case study series using the repertory grid technique.

PubMed

Schaffalitzky, Elisabeth; NiMhurchadha, Sinead; Gallagher, Pamela; Hofkamp, Susan; MacLachlan, Malcolm; Wegener, Stephen T

2009-06-01

The matching of prosthetic devices to the needs of the individual is a challenge for providers and patients. The aims of this study are to explore the values and preferences that prosthetic users have of their prosthetic devices; to investigate users' perceptions of alternative prosthetic options and to demonstrate a novel method for exploring the values and preferences of prosthetic users. This study describes four case studies of upper limb and lower limb high tech and conventional prosthetic users. Participants were interviewed using the repertory grid technique (RGT), a qualitative technique to explore individual values and preferences regarding specific choices and events. The participants generated distinctive patterns of personal constructs and ratings regarding prosthetic use and different prosthetic options available. The RGT produced a unique profile of preferences regarding prosthetic technologies for each participant. User choice is an important factor when matching prosthetic technology to the user. The consumer's values regarding different prosthetic options are likely to be a critical factor in prosthetic acceptance and ultimate quality of life. The RGT offers a structured method of exploring these attitudes and values without imposing researcher or practitioner bias and identifies personalized dimensions for providers and users to evaluate the individuals' preferences in prosthetic technology.

A radiograph positioning technique to evaluate prosthetic misfit and bone loss around implants.

PubMed

Lin, Kevin C; Wadhwani, Chandur P K; Sharma, Arun; Finzen, Frederick

2014-02-01

A radiograph positioning device was developed to fit with commercially available film holders and implant systems. The device is indexed to the dental implant body and the adjacent dentition by using an implant placement driver and polyvinyl siloxane occlusal registration material. By fitting the device to a conventional film holder, accurate orthogonal radiographs can monitor changes in bone architecture and prosthetic misfit. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3630 - Endosseous dental implant abutment.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

21 CFR 872.3275 - Dental cement.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental cement. 872.3275 Section 872.3275 Food and... DENTAL DEVICES Prosthetic Devices § 872.3275 Dental cement. (a) Zinc oxide-eugenol—(1) Identification... filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or...

21 CFR 872.3275 - Dental cement.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental cement. 872.3275 Section 872.3275 Food and... DENTAL DEVICES Prosthetic Devices § 872.3275 Dental cement. (a) Zinc oxide-eugenol—(1) Identification... filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or...

21 CFR 872.3275 - Dental cement.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental cement. 872.3275 Section 872.3275 Food and... DENTAL DEVICES Prosthetic Devices § 872.3275 Dental cement. (a) Zinc oxide-eugenol—(1) Identification... filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or...

21 CFR 872.3275 - Dental cement.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental cement. 872.3275 Section 872.3275 Food and... DENTAL DEVICES Prosthetic Devices § 872.3275 Dental cement. (a) Zinc oxide-eugenol—(1) Identification... filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or...

21 CFR 872.3275 - Dental cement.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental cement. 872.3275 Section 872.3275 Food and... DENTAL DEVICES Prosthetic Devices § 872.3275 Dental cement. (a) Zinc oxide-eugenol—(1) Identification... filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or...

Control System for Prosthetic Devices

NASA Technical Reports Server (NTRS)

Bozeman, Richard J. (Inventor)

1996-01-01

A control system and method for prosthetic devices is provided. The control system comprises a transducer for receiving movement from a body part for generating a sensing signal associated with that of movement. The sensing signal is processed by a linearizer for linearizing the sensing signal to be a linear function of the magnitude of the distance moved by the body part. The linearized sensing signal is normalized to be a function of the entire range of body part movement from the no-shrug position of the moveable body part through the full-shrg position of the moveable body part. The normalized signal is divided into a plurality of discrete command signals. The discrete command signals are used by typical converter devices which are in operational association with the prosthetic device. The converter device uses the discrete command signals for driving the moveable portions of the prosthetic device and its sub-prosthesis. The method for controlling a prosthetic device associated with the present invention comprises the steps of receiving the movement from the body part, generating a sensing signal in association with the movement of the body part, linearizing the sensing signal to be a linear function of the magnitude of the distance moved by the body part, normalizing the linear signal to be a function of the entire range of the body part movement, dividing the normalized signal into a plurality of discrete command signals, and implementing the plurality of discrete command signals for driving the respective moveable prosthesis device and its sub-prosthesis.

Control method for prosthetic devices

NASA Technical Reports Server (NTRS)

Bozeman, Richard J., Jr. (Inventor)

1995-01-01

A control system and method for prosthetic devices is provided. The control system comprises a transducer for receiving movement from a body part for generating a sensing signal associated with that movement. The sensing signal is processed by a linearizer for linearizing the sensing signal to be a linear function of the magnitude of the distance moved by the body part. The linearized sensing signal is normalized to be a function of the entire range of body part movement from the no-shrug position of the moveable body part. The normalized signal is divided into a plurality of discrete command signals. The discrete command signals are used by typical converter devices which are in operational association with the prosthetic device. The converter device uses the discrete command signals for driving the moveable portions of the prosthetic device and its sub-prosthesis. The method for controlling a prosthetic device associated with the present invention comprises the steps of receiving the movement from the body part, generating a sensing signal in association with the movement of the body part, linearizing the sensing signal to be a linear function of the magnitude of the distance moved by the body part, normalizing the linear signal to be a function of the entire range of the body part movement, dividing the normalized signal into a plurality of discrete command signals, and implementing the plurality of discrete command signals for driving the respective moveable prosthesis device and its sub-prosthesis.

Control system and method for prosthetic devices

NASA Technical Reports Server (NTRS)

Bozeman, Richard J., Jr. (Inventor)

1992-01-01

A control system and method for prosthetic devices is provided. The control system comprises a transducer for receiving movement from a body part for generating a sensing signal associated with that movement. The sensing signal is processed by a linearizer for linearizing the sensing signal to be a linear function of the magnitude of the distance moved by the body part. The linearized sensing signal is normalized to be a function of the entire range of body part movement from the no-shrug position of the movable body part through the full-shrug position of the movable body part. The normalized signal is divided into a plurality of discrete command signals. The discrete command signals are used by typical converter devices which are in operational association with the prosthetic device. The converter device uses the discrete command signals for driving the movable portions of the prosthetic device and its sub-prosthesis. The method for controlling a prosthetic device associated with the present invention comprises the steps of receiving the movement from the body part, generating a sensing signal in association with the movement of the body part, linearizing the sensing signal to be a linear function of the magnitude of the distance moved by the body part, normalizing the linear signal to be a function of the entire range of the body part movement, dividing the normalized signal into a plurality of discrete command signals, and implementing the plurality of discrete command signals for driving the respective movable prosthesis device and its sub-prosthesis.

Using computed tomography and 3D printing to construct custom prosthetics attachments and devices.

PubMed

Liacouras, Peter C; Sahajwalla, Divya; Beachler, Mark D; Sleeman, Todd; Ho, Vincent B; Lichtenberger, John P

2017-01-01

The prosthetic devices the military uses to restore function and mobility to our wounded warriors are highly advanced, and in many instances not publically available. There is considerable research aimed at this population of young patients who are extremely active and desire to take part in numerous complex activities. While prosthetists design and manufacture numerous devices with standard materials and limb assemblies, patients often require individualized prosthetic design and/or modifications to enable them to participate fully in complex activities. Prosthetists and engineers perform research and implement digitally designs in collaboration to generate equipment for their patient's rehabilitation needs. 3D printing allows for these devices to be manufactured from an array of materials ranging from plastic to titanium alloy. Many designs require form fitting to a prosthetic socket or a complex surface geometry. Specialty items can be scanned using computed tomography and digitally reconstructed to produce a virtual 3D model the engineer can use to design the necessary features of the desired prosthetic, device, or attachment. Completed devices are tested for fit and function. Numerous custom prostheses and attachments have been successfully translated from the research domain to clinical reality, in particular, those that feature the use of computed tomography (CT) reconstructions. The purpose of this project is to describe the research pathways to implementation for the following clinical designs: sets of bilateral hockey skates; custom weightlifting prosthetic hands; and a wine glass holder. This article will demonstrate how to incorporate CT imaging and 3D printing in the design and manufacturing process of custom attachments and assistive technology devices. Even though some of these prosthesis attachments may be relatively simple in design to an engineer, they have an enormous impact on the lives of our wounded warriors.

Designing for scale: development of the ReMotion Knee for global emerging markets.

PubMed

Hamner, Samuel R; Narayan, Vinesh G; Donaldson, Krista M

2013-09-01

Amputees living in developing countries have a profound need for affordable and reliable lower limb prosthetic devices. The World Health Organization estimates there are approximately 30 million amputees living in low-income countries, with up to 95% lacking access to prosthetic devices. Effective prosthetics can significantly affect the lives of these amputees by increasing opportunity for employment and providing improvements to long-term health and well-being. However, current solutions are inadequate: state-of-the-art solutions from the US and Europe are cost-prohibitive, while low-cost devices have been challenged by poor quality and/or unreliable performance, and have yet to achieve large scale impact. The introduction of new devices is hampered by the lack of a cohesive prosthetics industry in low-income areas; the current network of low-cost prosthetic clinics is informal and loosely organized with significant disparities in geography, patient volume and demographics, device procurement, clinical and logistical infrastructure, and funding. At D-Rev (Design Revolution) we are creating the ReMotion Knee, which is an affordable polycentric prosthetic knee joint that performs on par with devices in more industrialized regions, like the US and Europe. As of September 2012, over 4200 amputees have been fitted with the initial version of the ReMotion Knee through a partnership with the JaipurFoot Organization, with an 79% compliance rate after 2 years. We are currently scaling production of the ReMotion Knee using centralized manufacturing and distribution to serve the existing clinics in low-income countries and increase the availability of devices for amputees without access to appropriate care. At D-Rev, we develop products that target these customers through economically-sustainable models and provide a measurable impact in the lives of the world's amputees.

Literature Review on Needs of Upper Limb Prosthesis Users.

PubMed

Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

2016-01-01

The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses.

Literature Review on Needs of Upper Limb Prosthesis Users

PubMed Central

Cordella, Francesca; Ciancio, Anna Lisa; Sacchetti, Rinaldo; Davalli, Angelo; Cutti, Andrea Giovanni; Guglielmelli, Eugenio; Zollo, Loredana

2016-01-01

The loss of one hand can significantly affect the level of autonomy and the capability of performing daily living, working and social activities. The current prosthetic solutions contribute in a poor way to overcome these problems due to limitations in the interfaces adopted for controlling the prosthesis and to the lack of force or tactile feedback, thus limiting hand grasp capabilities. This paper presents a literature review on needs analysis of upper limb prosthesis users, and points out the main critical aspects of the current prosthetic solutions, in terms of users satisfaction and activities of daily living they would like to perform with the prosthetic device. The ultimate goal is to provide design inputs in the prosthetic field and, contemporary, increase user satisfaction rates and reduce device abandonment. A list of requirements for upper limb prostheses is proposed, grounded on the performed analysis on user needs. It wants to (i) provide guidelines for improving the level of acceptability and usefulness of the prosthesis, by accounting for hand functional and technical aspects; (ii) propose a control architecture of PNS-based prosthetic systems able to satisfy the analyzed user wishes; (iii) provide hints for improving the quality of the methods (e.g., questionnaires) adopted for understanding the user satisfaction with their prostheses. PMID:27242413

Feedforward control strategies of subjects with transradial amputation in planar reaching.

PubMed

Metzger, Anthony J; Dromerick, Alexander W; Schabowsky, Christopher N; Holley, Rahsaan J; Monroe, Brian; Lum, Peter S

2010-01-01

The rate of upper-limb amputations is increasing, and the rejection rate of prosthetic devices remains high. People with upper-limb amputation do not fully incorporate prosthetic devices into their activities of daily living. By understanding the reaching behaviors of prosthesis users, researchers can alter prosthetic devices and develop training protocols to improve the acceptance of prosthetic limbs. By observing the reaching characteristics of the nondisabled arms of people with amputation, we can begin to understand how the brain alters its motor commands after amputation. We asked subjects to perform rapid reaching movements to two targets with and without visual feedback. Subjects performed the tasks with both their prosthetic and nondisabled arms. We calculated endpoint error, trajectory error, and variability and compared them with those of nondisabled control subjects. We found no significant abnormalities in the prosthetic limb. However, we found an abnormal leftward trajectory error (in right arms) in the nondisabled arm of prosthetic users in the vision condition. In the no-vision condition, the nondisabled arm displayed abnormal leftward endpoint errors and abnormally higher endpoint variability. In the vision condition, peak velocity was lower and movement duration was longer in both arms of subjects with amputation. These abnormalities may reflect the cortical reorganization associated with limb loss.

Prosthetic Device Infections.

PubMed

Martinez, Raquel M; Bowen, Thomas R; Foltzer, Michael A

2016-08-01

The immunocompromised host is a particularly vulnerable population in whom routine and unusual infections can easily and frequently occur. Prosthetic devices are commonly used in these patients and the infections associated with those devices present a number of challenges for both the microbiologist and the clinician. Biofilms play a major role in device-related infections, which may contribute to failed attempts to recover organisms from routine culture methods. Moreover, device-related microorganisms can be difficult to eradicate by antibiotic therapy alone. Changes in clinical practice and advances in laboratory diagnostics have provided significant improvements in the detection and accurate diagnosis of device-related infections. Disruption of the bacterial biofilm plays an essential role in recovering the causative agent in culture. Various culture and nucleic acid amplification techniques are more accurate to guide directed treatment regimens. This chapter reviews the performance characteristics of currently available diagnostic assays and summarizes published guidelines, where available, for addressing suspected infected prosthetic devices.

Device to monitor sock use in people using prosthetic limbs: technical report.

PubMed

Sanders, Joan E; Murthy, Revathi; Cagle, John C; Allyn, Katheryn J; Phillips, Reid H; Otis, Brian P

2012-01-01

A device using radio frequency identification (RFID) technology was developed to continuously monitor sock use in people who use prosthetic limbs. RFID tags were placed on prosthetic socks worn by subjects with transtibial limb loss, and a high-frequency RFID reader and antenna were placed in a portable unit mounted to the outside of the prosthetic socket. Bench testing showed the device to have a maximum read range between 5.6 cm and 12.7 cm, depending on the RFID tag used. Testing in a laboratory setting on three participants with transtibial amputation showed that the device correctly monitored sock presence during sitting, standing, and walking activity when one or two socks were worn but was less reliable when more socks were used. Accurate detection was sensitive to orientation of the tag relative to the reader, presence of carbon fiber in the prosthetic socket, pistoning of the limb in the socket, and overlap among the tags. Use of ultra-high-frequency RFID may overcome these limitations. With improvements, the technology may prove useful to practitioners prescribing volume accommodation strategies for patients by providing information about sock use between clinical visits, including timing and consistency of daily sock-ply changes.

Technical Report: A device to monitor sock use on people using prosthetic limbs

PubMed Central

Sanders, Joan; Murthy, Revathi; Cagle, John; Allyn, Katheryn; Phillips, Reid

2015-01-01

A device using radio frequency identification technology (RFID) was developed to continuously monitor sock use on people using prosthetic limbs. RFID tags were placed on prosthetic socks worn by subjects with transtibial limb loss, and a high-frequency (HF) RFID reader and antenna were placed in a portable unit mounted to the outside of the prosthetic socket. Bench testing showed the device to have a maximum read range between 5.6 cm and 12.7 cm, depending on the RFID tag used. Testing in a laboratory setting on three participants with transtibial amputation showed that the device correctly monitored sock presence during sitting, standing, and walking activity when one or two socks were worn but was less reliable when more socks were used. Accurate detection was sensitive to orientation of the tag relative to the reader, presence of carbon fiber in the prosthetic socket, pistoning of the limb in the socket, and overlap among the tags. Use of ultra high frequency (UHF) RFID may overcome these limitations. With improvements, the technology may prove useful to practitioners prescribing volume accommodation strategies for patients by providing information about sock use between clinical visits, including timing and consistency of daily sock ply changes. PMID:23341315

Attenuation of centre-of-pressure trajectory fluctuations under the prosthetic foot when using an articulating hydraulic ankle attachment compared to fixed attachment.

PubMed

De Asha, Alan R; Johnson, Louise; Munjal, Ramesh; Kulkarni, Jai; Buckley, John G

2013-02-01

Disruptions to the progress of the centre-of-pressure trajectory beneath prosthetic feet have been reported previously. These disruptions reflect how body weight is transferred over the prosthetic limb and are governed by the compliance of the prosthetic foot device and its ability to simulate ankle function. This study investigated whether using an articulating hydraulic ankle attachment attenuates centre-of-pressure trajectory fluctuations under the prosthetic foot compared to a fixed attachment. Twenty active unilateral trans-tibial amputees completed walking trials at their freely-selected, comfortable walking speed using both their habitual foot with either a rigid or elastic articulating attachment and a foot with a hydraulic ankle attachment. Centre-of-pressure displacement and velocity fluctuations beneath the prosthetic foot, prosthetic shank angular velocity during stance, and walking speed were compared between foot conditions. Use of the hydraulic device eliminated or reduced the magnitude of posteriorly directed centre-of-pressure displacements, reduced centre-of-pressure velocity variability across single-support, increased mean forward angular velocity of the shank during early stance, and increased freely chosen comfortable walking speed (P ≤ 0.002). The attenuation of centre-of-pressure trajectory fluctuations when using the hydraulic device indicated bodyweight was transferred onto the prosthetic limb in a smoother, less faltering manner which allowed the centre of mass to translate more quickly over the foot. Copyright © 2012 Elsevier Ltd. All rights reserved.

38 CFR 17.150 - Prosthetic and similar appliances.

Code of Federal Regulations, 2010 CFR

2010-07-01

... appliances. 17.150 Section 17.150 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Prosthetic, Sensory, and Rehabilitative Aids § 17.150 Prosthetic and similar appliances... appliances including invalid lifts and therapeutic and rehabilitative devices, and special clothing made...

Pilot Study for OCT Guided Design and Fit of a Prosthetic Device for Treatment of Corneal Disease.

PubMed

Le, Hong-Gam T; Tang, Maolong; Ridges, Ryan; Huang, David; Jacobs, Deborah S

2012-01-01

Purpose. To assess optical coherence tomography (OCT) for guiding design and fit of a prosthetic device for corneal disease. Methods. A prototype time domain OCT scanner was used to image the anterior segment of patients fitted with large diameter (18.5-20 mm) prosthetic devices for corneal disease. OCT images were processed and analyzed to characterize corneal diameter, corneal sagittal height, scleral sagittal height, scleral toricity, and alignment of device. Within-subject variance of OCT-measured parameters was evaluated. OCT-measured parameters were compared with device parameters for each eye fitted. OCT image correspondence with ocular alignment and clinical fit was assessed. Results. Six eyes in 5 patients were studied. OCT measurement of corneal diameter (coefficient of variation, CV = 0.76%), cornea sagittal height (CV = 2.06%), and scleral sagittal height (CV = 3.39%) is highly repeatable within each subject. OCT image-derived measurements reveal strong correlation between corneal sagittal height and device corneal height (r = 0.975) and modest correlation between scleral and on-eye device toricity (r = 0.581). Qualitative assessment of a fitted device on OCT montages reveals correspondence with slit lamp images and clinical assessment of fit. Conclusions. OCT imaging of the anterior segment is suitable for custom design and fit of large diameter (18.5-20 mm) prosthetic devices used in the treatment of corneal disease.

Progressive upper limb prosthetics.

PubMed

Lake, Chris; Dodson, Robert

2006-02-01

The field of upper extremity prosthetics is a constantly changing arena as researchers and prosthetists strive to bridge the gap between prosthetic reality and upper limb physiology. With the further development of implantable neurologic sensing devices and targeted muscle innervation (discussed elsewhere in this issue), the challenge of limited input to control vast outputs promises to become a historical footnote in the future annals of upper limb prosthetics. Soon multidextrous terminal devices, such as that found in the iLimb system(Touch EMAS, Inc., Edinburgh, UK), will be a clinical reality (Fig. 22). Successful prosthetic care depends on good communication and cooperation among the surgeon, the amputee, the rehabilitation team, and the scientists harnessing the power of technology to solve real-life challenges. If the progress to date is any indication, amputees of the future will find their dreams limited only by their imagination.

Innovations in prosthetic interfaces for the upper extremity.

PubMed

Kung, Theodore A; Bueno, Reuben A; Alkhalefah, Ghadah K; Langhals, Nicholas B; Urbanchek, Melanie G; Cederna, Paul S

2013-12-01

Advancements in modern robotic technology have led to the development of highly sophisticated upper extremity prosthetic limbs. High-fidelity volitional control of these devices is dependent on the critical interface between the patient and the mechanical prosthesis. Recent innovations in prosthetic interfaces have focused on several control strategies. Targeted muscle reinnervation is currently the most immediately applicable prosthetic control strategy and is particularly indicated in proximal upper extremity amputations. Investigation into various brain interfaces has allowed acquisition of neuroelectric signals directly or indirectly from the central nervous system for prosthetic control. Peripheral nerve interfaces permit signal transduction from both motor and sensory nerves with a higher degree of selectivity. This article reviews the current developments in each of these interface systems and discusses the potential of these approaches to facilitate motor control and sensory feedback in upper extremity neuroprosthetic devices.

Learning from demonstration: Teaching a myoelectric prosthesis with an intact limb via reinforcement learning.

PubMed

Vasan, Gautham; Pilarski, Patrick M

2017-07-01

Prosthetic arms should restore and extend the capabilities of someone with an amputation. They should move naturally and be able to perform elegant, coordinated movements that approximate those of a biological arm. Despite these objectives, the control of modern-day prostheses is often nonintuitive and taxing. Existing devices and control approaches do not yet give users the ability to effect highly synergistic movements during their daily-life control of a prosthetic device. As a step towards improving the control of prosthetic arms and hands, we introduce an intuitive approach to training a prosthetic control system that helps a user achieve hard-to-engineer control behaviours. Specifically, we present an actor-critic reinforcement learning method that for the first time promises to allow someone with an amputation to use their non-amputated arm to teach their prosthetic arm how to move through a wide range of coordinated motions and grasp patterns. We evaluate our method during the myoelectric control of a multi-joint robot arm by non-amputee users, and demonstrate that by using our approach a user can train their arm to perform simultaneous gestures and movements in all three degrees of freedom in the robot's hand and wrist based only on information sampled from the robot and the user's above-elbow myoelectric signals. Our results indicate that this learning-from-demonstration paradigm may be well suited to use by both patients and clinicians with minimal technical knowledge, as it allows a user to personalize the control of his or her prosthesis without having to know the underlying mechanics of the prosthetic limb. These preliminary results also suggest that our approach may extend in a straightforward way to next-generation prostheses with precise finger and wrist control, such that these devices may someday allow users to perform fluid and intuitive movements like playing the piano, catching a ball, and comfortably shaking hands.

Theoretical Study on the Mechanics of the Conjunct Gnatoprothetic Devices in the Context of Occlusive Function Rehabilitation

PubMed Central

POPESCU, M.R.; TRANĂ, F.; MANOLEA, H.; RAUTEN, ANE-MARIE; ȘURLIN, PETRA; DRAGOMIR, L.P.

2014-01-01

The partially intercalated edentation offers the practitioner the possibility of the functional rehabilitation of the dental arcades through conjunct gnato-prosthetic devices. The functions of the dento-maxilar device, disturbed by the presence of edentation, require a treatment approach so that, without pre-planning or estimating, the result can lead most of the times to failure in terms of functionality. Clinical evaluation associated with pre- and proprosthetic treatment can also impose, in some situations the evaluation of the dental units involved in prosthetic rehabilitation. The association and implementation of the prosthetic construction in the occlusive-articular ensemble, as well as the counterbalancing of the mastication forces per dental unit and whole interarch system, linked to the distribution of the forces at the level of the pillar teeth and prosthetic construction, represent the goal of this theoretical study. PMID:25729593

Theoretical study on the mechanics of the conjunct gnatoprothetic devices in the context of occlusive function rehabilitation.

PubMed

Popescu, M R; Trană, F; Manolea, H; Rauten, Ane-Marie; Șurlin, Petra; Dragomir, L P

2014-01-01

The partially intercalated edentation offers the practitioner the possibility of the functional rehabilitation of the dental arcades through conjunct gnato-prosthetic devices. The functions of the dento-maxilar device, disturbed by the presence of edentation, require a treatment approach so that, without pre-planning or estimating, the result can lead most of the times to failure in terms of functionality. Clinical evaluation associated with pre- and proprosthetic treatment can also impose, in some situations the evaluation of the dental units involved in prosthetic rehabilitation. The association and implementation of the prosthetic construction in the occlusive-articular ensemble, as well as the counterbalancing of the mastication forces per dental unit and whole interarch system, linked to the distribution of the forces at the level of the pillar teeth and prosthetic construction, represent the goal of this theoretical study.

Interface Prostheses With Classifier-Feedback-Based User Training.

PubMed

Fang, Yinfeng; Zhou, Dalin; Li, Kairu; Liu, Honghai

2017-11-01

It is evident that user training significantly affects performance of pattern-recognition-based myoelectric prosthetic device control. Despite plausible classification accuracy on offline datasets, online accuracy usually suffers from the changes in physiological conditions and electrode displacement. The user ability in generating consistent electromyographic (EMG) patterns can be enhanced via proper user training strategies in order to improve online performance. This study proposes a clustering-feedback strategy that provides real-time feedback to users by means of a visualized online EMG signal input as well as the centroids of the training samples, whose dimensionality is reduced to minimal number by dimension reduction. Clustering feedback provides a criterion that guides users to adjust motion gestures and muscle contraction forces intentionally. The experiment results have demonstrated that hand motion recognition accuracy increases steadily along the progress of the clustering-feedback-based user training, while conventional classifier-feedback methods, i.e., label feedback, hardly achieve any improvement. The result concludes that the use of proper classifier feedback can accelerate the process of user training, and implies prosperous future for the amputees with limited or no experience in pattern-recognition-based prosthetic device manipulation.It is evident that user training significantly affects performance of pattern-recognition-based myoelectric prosthetic device control. Despite plausible classification accuracy on offline datasets, online accuracy usually suffers from the changes in physiological conditions and electrode displacement. The user ability in generating consistent electromyographic (EMG) patterns can be enhanced via proper user training strategies in order to improve online performance. This study proposes a clustering-feedback strategy that provides real-time feedback to users by means of a visualized online EMG signal input as well as the centroids of the training samples, whose dimensionality is reduced to minimal number by dimension reduction. Clustering feedback provides a criterion that guides users to adjust motion gestures and muscle contraction forces intentionally. The experiment results have demonstrated that hand motion recognition accuracy increases steadily along the progress of the clustering-feedback-based user training, while conventional classifier-feedback methods, i.e., label feedback, hardly achieve any improvement. The result concludes that the use of proper classifier feedback can accelerate the process of user training, and implies prosperous future for the amputees with limited or no experience in pattern-recognition-based prosthetic device manipulation.

Cobotic architecture for prosthetics.

PubMed

Faulring, Eeic L; Colgate, J Edward; Peshkin, Michael A

2006-01-01

We envision cobotic infinitely-variable transmissions (IVTs) as an enabling technology for haptics and prosthetics that will allow for increases in the dynamic range of these devices while simultaneously permitting reductions in actuator size and power requirements. Use of cobotic IVTs eliminates the need to make compromises on output flow and effort, which are inherent to choosing a fixed transmission ratio drivetrain. The result is a mechanism with enhanced dynamic range that extends continuously from a completely clutched state to a highly backdrivable state. This high dynamic range allows cobotic devices to control impedance with a high level of fidelity. In this paper, we discuss these and other motivations for using parallel cobotic transmission architecture in prosthetic devices.

Golf hand prosthesis performance of transradial amputees.

PubMed

Carey, Stephanie L; Wernke, Matthew M; Lura, Derek J; Kahle, Jason T; Dubey, Rajiv V; Highsmith, M Jason

2015-06-01

Typical upper limb prostheses may limit sports participation; therefore, specialized terminal devices are often needed. The purpose of this study was to evaluate the ability of transradial amputees to play golf using a specialized terminal device. Club head speed, X-factor, and elbow motion of two individuals with transradial amputations using an Eagle Golf terminal device were compared to a non-amputee during a golf swing. Measurements were collected pre/post training with various stances and grips. Both prosthesis users preferred a right-handed stance initially; however, after training, one preferred a left-handed stance. The amputees had slower club head speeds and a lower X-factor compared to the non-amputee golfer, but increased their individual elbow motion on the prosthetic side after training. Amputees enjoyed using the device, and it may provide kinematic benefits indicated by the increase in elbow flexion on the prosthetic side. The transradial amputees were able to swing a golf club with sufficient repetition, form, and velocity to play golf recreationally. Increased elbow flexion on the prosthetic side suggests a potential benefit from using the Eagle Golf terminal device. Participating in recreational sports can increase amputees' health and quality of life. © The International Society for Prosthetics and Orthotics 2014.

Surface EMG and intra-socket force measurement to control a prosthetic device

NASA Astrophysics Data System (ADS)

Sanford, Joe; Patterson, Rita; Popa, Dan

2015-06-01

Surface electromyography (SEMG) has been shown to be a robust and reliable interaction method allowing for basic control of powered prosthetic devices. Research has shown a marked decrease in EMG-classification efficiency throughout activities of daily life due to socket shift and movement and fatigue as well as changes in degree of fit of the socket throughout the subject's lifetime. Users with the most severe levels of amputation require the most complex devices with the greatest number of degrees of freedom. Controlling complex dexterous devices with limited available inputs requires the addition of sensing and interaction modalities. However, the larger the amputation severity, the fewer viable SEMG sites are available as control inputs. Previous work reported the use of intra-socket pressure, as measured during wrist flexion and extension, and has shown that it is possible to control a powered prosthetic device with pressure sensors. In this paper, we present data correlations of SEMG data with intra-socket pressure data. Surface EMG sensors and force sensors were housed within a simulated prosthetic cuff fit to a healthy-limbed subject. EMG and intra-socket force data was collected from inside the cuff as a subject performed pre-defined grip motions with their dominant hand. Data fusion algorithms were explored and allowed a subject to use both intra-socket pressure and SEMG data as control inputs for a powered prosthetic device. This additional input modality allows for an improvement in input classification as well as information regarding socket fit through out activities of daily life.

Impact on the biomechanics of overground gait of using an 'Echelon' hydraulic ankle-foot device in unilateral trans-tibial and trans-femoral amputees.

PubMed

De Asha, Alan R; Munjal, Ramesh; Kulkarni, Jai; Buckley, John G

2014-08-01

If a prosthetic foot creates resistance to forwards shank rotation as it deforms during loading, it will exert a braking effect on centre of mass progression. The present study determines whether the centre of mass braking effect exerted by an amputee's habitual rigid 'ankle' foot was reduced when they switched to using an 'Echelon' hydraulic ankle-foot device. Nineteen lower limb amputees (eight trans-femoral, eleven trans-tibial) walked overground using their habitual dynamic-response foot with rigid 'ankle' or 'Echelon' hydraulic ankle-foot device. Analysis determined changes in how the centre of mass was transferred onto and above the prosthetic-foot, freely chosen walking speed, and spatio-temporal parameters of gait. When using the hydraulic device both groups had a smoother/more rapid progression of the centre of pressure beneath the prosthetic hindfoot (p≤0.001), and a smaller reduction in centre of mass velocity during prosthetic-stance (p<0.001). As a result freely chosen walking speed was higher in both groups when using the device (p≤0.005). In both groups stance and swing times and cadence were unaffected by foot condition whereas step length tended (p<0.07) to increase bilaterally when using the hydraulic device. Effect size differences between foot types were comparable across groups. Use of a hydraulic ankle-foot device reduced the foot's braking effect for both amputee groups. Findings suggest that attenuation of the braking effect from the foot in early stance may be more important to prosthetic-foot function than its ability to return energy in late stance. Copyright © 2014. Published by Elsevier Ltd.

Cyborg beast: a low-cost 3d-printed prosthetic hand for children with upper-limb differences.

PubMed

Zuniga, Jorge; Katsavelis, Dimitrios; Peck, Jean; Stollberg, John; Petrykowski, Marc; Carson, Adam; Fernandez, Cristina

2015-01-20

There is an increasing number of children with traumatic and congenital hand amputations or reductions. Children's prosthetic needs are complex due to their small size, constant growth, and psychosocial development. Families' financial resources play a crucial role in the prescription of prostheses for their children, especially when private insurance and public funding are insufficient. Electric-powered (i.e., myoelectric) and body-powered (i.e., mechanical) devices have been developed to accommodate children's needs, but the cost of maintenance and replacement represents an obstacle for many families. Due to the complexity and high cost of these prosthetic hands, they are not accessible to children from low-income, uninsured families or to children from developing countries. Advancements in computer-aided design (CAD) programs, additive manufacturing, and image editing software offer the possibility of designing, printing, and fitting prosthetic hands devices at a distance and at very low cost. The purpose of this preliminary investigation was to describe a low-cost three-dimensional (3D)-printed prosthetic hand for children with upper-limb reductions and to propose a prosthesis fitting methodology that can be performed at a distance. No significant mean differences were found between the anthropometric and range of motion measurements taken directly from the upper limbs of subjects versus those extracted from photographs. The Bland and Altman plots show no major bias and narrow limits of agreements for lengths and widths and small bias and wider limits of agreements for the range of motion measurements. The main finding of the survey was that our prosthetic device may have a significant potential to positively impact quality of life and daily usage, and can be incorporated in several activities at home and in school. This investigation describes a low-cost 3D-printed prosthetic hand for children and proposes a distance fitting procedure. The Cyborg Beast prosthetic hand and the proposed distance-fitting procedures may represent a possible low-cost alternative for children in developing countries and those who have limited access to health care providers. Further studies should examine the functionality, validity, durability, benefits, and rejection rate of this type of low-cost 3D-printed prosthetic device.

Power feasibility of implantable digital spike sorting circuits for neural prosthetic systems.

PubMed

Zumsteg, Zachary S; Kemere, Caleb; O'Driscoll, Stephen; Santhanam, Gopal; Ahmed, Rizwan E; Shenoy, Krishna V; Meng, Teresa H

2005-09-01

A new class of neural prosthetic systems aims to assist disabled patients by translating cortical neural activity into control signals for prosthetic devices. Based on the success of proof-of-concept systems in the laboratory, there is now considerable interest in increasing system performance and creating implantable electronics for use in clinical systems. A critical question that impacts system performance and the overall architecture of these systems is whether it is possible to identify the neural source of each action potential (spike sorting) in real-time and with low power. Low power is essential both for power supply considerations and heat dissipation in the brain. In this paper we report that state-of-the-art spike sorting algorithms are not only feasible using modern complementary metal oxide semiconductor very large scale integration processes, but may represent the best option for extracting large amounts of data in implantable neural prosthetic interfaces.

Survey of upper limb prosthesis users in Sweden, the United Kingdom and Canada.

PubMed

Kyberd, Peter J; Hill, Wendy

2011-06-01

As part of the process of improving prosthetic arms, it is important to obtain the opinions of the user population. To identify factors that should be focused on to improve prosthesis provision. Postal questionnaire. The questionnaire was sent to 292 adults (aged 18 to 70 years) with upper-limb loss or absence at five centres (four in Europe) Participants were identified as regular attendees of the centres. This questionnaire received a response from 180 users (response rate 62%) of different types of prosthetic devices. Responses showed that the type of prosthesis generally used was associated with gender, level of loss and use for work (Pearson chi-square, p-values below 0.05). The type of prosthesis was not associated with cause, side, usage (length per day, sports or driving) or reported problems. The findings did not identify any single factor requiring focus for the improvement of prostheses or prosthetic provision. Every part of the process of fitting a prosthesis can be improved, which will have an effect for some of the population who use their devices regularly. There is, however, no single factor that would bring greater improvement to all users. Based on information gained from a broad range of prosthesis users, no single aspect of prosthetic provision will have a greater impact on the use of upper limb prostheses than any other. Efforts to improve the designs of prosthetic systems can cover any aspect of provision.

Simulation of a sensor array for multiparameter measurements at the prosthetic limb interface

NASA Astrophysics Data System (ADS)

Rowe, Gabriel I.; Mamishev, Alexander V.

2004-07-01

Sensitive skin is a highly desired device for biomechanical devices, wearable computing, human-computer interfaces, exoskeletons, and, most pertinent to this paper, for lower limb prosthetics. The measurement of shear stress is very important because shear effects are key factors in developing surface abrasions and pressure sores in paraplegics and users of prosthetic/orthotic devices. A single element of a sensitive skin is simulated and characterized in this paper. Conventional tactile sensors are designed for measurement of the normal stress only, which is inadequate for comprehensive assessment of surface contact conditions. The sensitive skin discussed here is a flexible array capable of sensing shear and normal forces, as well as humidity and temperature on each element.

Development of novel 3D-printed robotic prosthetic for transradial amputees.

PubMed

Gretsch, Kendall F; Lather, Henry D; Peddada, Kranti V; Deeken, Corey R; Wall, Lindley B; Goldfarb, Charles A

2016-06-01

Upper extremity myoelectric prostheses are expensive. The Robohand demonstrated that three-dimensional printing reduces the cost of a prosthetic extremity. The goal of this project was to develop a novel, inexpensive three-dimensional printed prosthesis to address limitations of the Robohand. The prosthesis was designed for patients with transradial limb amputation. It is shoulder-controlled and externally powered with an anthropomorphic terminal device. The user can open and close all five fingers, and move the thumb independently. The estimated cost is US$300. After testing on a patient with a traumatic transradial amputation, several advantages were noted. The independent thumb movement facilitated object grasp, the device weighed less than most externally powered prostheses, and the size was easily scalable. Limitations of the new prosthetic include low grip strength and decreased durability compared to passive prosthetics. Most children with a transradial congenital or traumatic amputation do not use a prosthetic. A three-dimensional printed shoulder-controlled robotic prosthesis provides a cost effective, easily sized and highly functional option which has been previously unavailable. © The International Society for Prosthetics and Orthotics 2015.

Hydrodynamic endurance test of the prosthetic valve used in the various types of the ventricular assist device.

PubMed

Nitta, S; Yambe, T; Katahira, Y; Sonobe, T; Saijoh, Y; Naganuma, S; Akiho, H; Kakinuma, Y; Tanaka, M; Miura, M

1991-12-01

To evaluate the various basic designs of the pump chambers used in the ventricular assist devices (VADs), hydrodynamic endurance test was performed from the viewpoint of the durability of the prosthetic valves used in the VAD. For the hydrodynamic analysis, we designed three basic types of pump (sac type, diaphragm type, and pusher plate type) using the same material and having the same capacity and shape. Prosthetic valves in these VADs were tested from the standpoint of the water hammer effect, which affects the valve durability, to determine which pump design would be most durable as a prosthetic valve in the VAD. The water-hammer phenomenon was evaluated using the maximum pressure gradient (MPG) across the prosthetic valve in the moc circulatory loop. Maximum pump output was recorded when we used the diaphragm type model, and minimum MPG in the commonly used driving condition of the VAD were recorded when we used the sac type model. The results suggest that the sac type VAD model is the most durable design for the prosthetic value.

Smartphones as image processing systems for prosthetic vision.

PubMed

Zapf, Marc P; Matteucci, Paul B; Lovell, Nigel H; Suaning, Gregg J

2013-01-01

The feasibility of implants for prosthetic vision has been demonstrated by research and commercial organizations. In most devices, an essential forerunner to the internal stimulation circuit is an external electronics solution for capturing, processing and relaying image information as well as extracting useful features from the scene surrounding the patient. The capabilities and multitude of image processing algorithms that can be performed by the device in real-time plays a major part in the final quality of the prosthetic vision. It is therefore optimal to use powerful hardware yet to avoid bulky, straining solutions. Recent publications have reported of portable single-board computers fast enough for computationally intensive image processing. Following the rapid evolution of commercial, ultra-portable ARM (Advanced RISC machine) mobile devices, the authors investigated the feasibility of modern smartphones running complex face detection as external processing devices for vision implants. The role of dedicated graphics processors in speeding up computation was evaluated while performing a demanding noise reduction algorithm (image denoising). The time required for face detection was found to decrease by 95% from 2.5 year old to recent devices. In denoising, graphics acceleration played a major role, speeding up denoising by a factor of 18. These results demonstrate that the technology has matured sufficiently to be considered as a valid external electronics platform for visual prosthetic research.

Nitinol for Prosthetic and Orthotic Applications

NASA Astrophysics Data System (ADS)

Henderson, Emma; Buis, Arjan

2011-07-01

As global populations age, conditions such as stroke and diabetes require individuals to use rehabilitation technology for many years to come due to chronic musculoskeletal, sensory, and other physical impairments. One in four males currently aged 45 will experience a stroke within 40 years and will often require access to prolonged rehabilitation. In addition, worldwide, one individual loses a limb every 30 s due to the complications of diabetes. As a result, innovative ideas are required to devise more effective prosthetic and orthotic devices to enhance quality of life. While Nitinol has already found much favor within the biomedical industry, one area, which has not yet exploited its unique properties, is in the field of physical rehabilitation, ranging from prosthetic and orthotic devices to assistive technology such as wheelchairs. Improved intervention capabilities based on materials such as Nitinol have the potential to vastly improve patients' quality of life and in the case of orthoses, may even reduce the severity of the condition over time. It is hoped that this study will spark discussion and interest for the materials community in a field which has yet to be fully exploited.

A personalized 3D-printed prosthetic joint replacement for the human temporomandibular joint: From implant design to implantation.

PubMed

Ackland, David C; Robinson, Dale; Redhead, Michael; Lee, Peter Vee Sin; Moskaljuk, Adrian; Dimitroulis, George

2017-05-01

Personalized prosthetic joint replacements have important applications in cases of complex bone and joint conditions where the shape and size of off-the-shelf components may not be adequate. The objective of this study was to design, test and fabricate a personalized 3D-printed prosthesis for a patient requiring total joint replacement surgery of the temporomandibular joint (TMJ). The new 'Melbourne' prosthetic TMJ design featured a condylar component sized specifically to the patient and fixation screw positions that avoid potential intra-operative damage to the mandibular nerve. The Melbourne prosthetic TMJ was developed for a 58-year-old female recipient with end-stage osteoarthritis of the TMJ. The load response of the prosthesis during chewing and a maximum-force bite was quantified using a personalized musculoskeletal model of the patient's masticatory system developed using medical images. The simulations were then repeated after implantation of the Biomet Microfixation prosthetic TMJ, an established stock device. The maximum condylar stresses, screw stress and mandibular stress at the screw-bone interface were lower in the Melbourne prosthetic TMJ (259.6MPa, 312.9MPa and 198.4MPa, respectively) than those in the Biomet Microfixation device (284.0MPa, 416.0MPa and 262.2MPa, respectively) during the maximum-force bite, with similar trends also observed during the chewing bite. After trialing surgical placement and evaluating prosthetic TMJ stability using cadaveric specimens, the prosthesis was fabricated using 3D printing, sterilized, and implanted into the female recipient. Six months post-operatively, the prosthesis recipient had a normal jaw opening distance (40.0 mm), with no complications identified. The new design features and immediate load response of the Melbourne prosthetic TMJ suggests that it may provide improved clinical and biomechanical joint function compared to a commonly used stock device, and reduce risk of intra-operative nerve damage during placement. The framework presented may be useful for designing and testing customized devices for the treatment of debilitating bone and joint conditions. Copyright © 2017 Elsevier Ltd. All rights reserved.

Utilization of penile prosthesis and male incontinence prosthetics in Saudi Arabia.

PubMed

Alwaal, Amjad; Al-Sayyad, Ahmad J

2017-01-01

Erectile dysfunction is a prevalent disease affecting over 50% of men between the ages of 40 and 70 years. Penile prosthesis represents the end of the line treatment when other less invasive therapies fail or are contraindicated. Male stress urinary incontinence can significantly diminish quality of life and lead to embarrassment and social withdrawal. Surgical therapies, such as male urethral slings and artificial urinary sphincters (AUS), are considered effective and safe treatments for male stress incontinence. No data exist on the utilization of penile prosthesis or male incontinence surgical treatment in Saudi Arabia. Generally, urological prosthetic surgery is performed either in private hospitals or in government hospitals. Our aim was to assess the trend of penile prosthesis and male incontinence device utilization in Saudi Arabia. We utilized sales' data of penile prosthetics, male slings, and AUS from the only two companies selling these devices in Saudi Arabia (AMS ® and Coloplast ® ), from January 2013 to December 2016. There were 2599 penile prosthesis implantation procedures done in the study period, with 67% of them performed in private institutions. There was a progressively increased use of penile prosthetics which nearly doubled from 2013 to 2016. The main type of prosthesis utilized was the semirigid type 70% versus 11% of the 2-piece inflatable and 17% of the 3-piece inflatable device. Only 10 slings and 31 AUS were inserted during the same study period. There is an increased utilization of penile prosthetics in Saudi Arabia. The private sector performs the majority of penile prosthesis procedures, and most of them are of the semirigid type. The governmental sector is more likely to perform inflatable penile prosthesis and male incontinence device procedures. Male incontinence prosthetics' use is very limited in Saudi Arabia.

Advances in Retinal Prosthetic Research: A Systematic Review of Engineering and Clinical Characteristics of Current Prosthetic Initiatives.

PubMed

Cheng, Derrick L; Greenberg, Paul B; Borton, David A

2017-03-01

To date, reviews of retinal prostheses have focused primarily on devices undergoing human trials in the Western Hemisphere and fail to capture significant advances in materials and engineering research in countries such as Japan and Korea, as well as projects in early stages of development. To address these gaps, this systematic review examines worldwide advances in retinal prosthetic research, evaluates engineering characteristics and clinical progress of contemporary device initiatives, and identifies potential directions for future research in the field of retinal prosthetics. A literature search using PubMed, Google Scholar, and IEEExplore was conducted following the PRISMA Guidelines for Systematic Review. Inclusion criteria were peer-reviewed papers demonstrating progress in human or animal trials and papers discussing the prosthetic engineering design. For each initiative, a description of the device, its engineering considerations, and recent clinical results were provided. Ten prosthetic initiatives met our inclusion criteria and were organized by stimulation location. Of these initiatives, four have recently completed human trials, three are undergoing multi- or single-center human trials, and three are undergoing preclinical animal testing. Only the Argus II (FDA 2013, CE 2011) has obtained FDA approval for use in the United States; the Alpha-IMS (CE 2013) has achieved the highest visual acuity using a Landolt-C test to date and is the only device presently undergoing a multicenter clinical trial. Several distinct approaches to retinal stimulation have been successful in eliciting visual precepts in animals and/or humans. However, many clinical needs are still not met and engineering challenges must be addressed before a retinal prosthesis with the capability to fully and safely restore functional vision can be realized.

Hybrid nanostructured coating for increased resistance of prosthetic devices to staphylococcal colonization

NASA Astrophysics Data System (ADS)

Anghel, Ion; Grumezescu, Alexandru Mihai

2013-01-01

Prosthetic medical device-associated infections are responsible for significant morbidity and mortality rates. Novel improved materials and surfaces exhibiting inappropriate conditions for microbial development are urgently required in the medical environment. This study reveals the benefit of using natural Mentha piperita essential oil, combined with a 5 nm core/shell nanosystem-improved surface exhibiting anti-adherence and antibiofilm properties. This strategy reveals a dual role of the nano-oil system; on one hand, inhibiting bacterial adherence and, on the other hand, exhibiting bactericidal effect, the core/shell nanosystem is acting as a controlled releasing machine for the essential oil. Our results demonstrate that this dual nanobiosystem is very efficient also for inhibiting biofilm formation, being a good candidate for the design of novel material surfaces used for prosthetic devices.

Simulating The Technological Movements Of The Equipment Used For Manufacturing Prosthetic Devices Using 3D Models

NASA Astrophysics Data System (ADS)

Chicea, Anca-Lucia

2015-09-01

The paper presents the process of building geometric and kinematic models of a technological equipment used in the process of manufacturing devices. First, the process of building the model for a six axes industrial robot is presented. In the second part of the paper, the process of building the model for a five-axis CNC milling machining center is also shown. Both models can be used for accurate cutting processes simulation of complex parts, such as prosthetic devices.

Power feasibility of implantable digital spike-sorting circuits for neural prosthetic systems.

PubMed

Zumsteg, Zachary S; Ahmed, Rizwan E; Santhanam, Gopal; Shenoy, Krishna V; Meng, Teresa H

2004-01-01

A new class of neural prosthetic systems aims to assist disabled patients by translating cortical neural activity into control signals for prosthetic devices. Based on the success of proof-of-concept systems in the laboratory, there is now considerable interest in increasing system performance and creating implantable electronics for use in clinical systems. A critical question that impacts system performance and the overall architecture of these systems is whether it is possible to identify the neural source of each action potential (spike sorting) in real-time and with low power. Low power is essential both for power supply considerations and heat dissipation in the brain. In this paper we report that several state-of-the-art spike sorting algorithms implemented in modern CMOS VLSI processes are expected to be power realistic.

[Acrylic resin reinforcement with metallic and nonmetallic inserts].

PubMed

Preoteasa, Elena; Murariu, Cătălina Măgureanu; Ionescu, Ecaterina; Preoteasa, Cristina Teodora

2007-01-01

In the current use of acrylic resin for removable dentures and orthodontic treatments we are frequently facing the fact of base fracture. The repairing of this, determine most of the time, discomfort of the patient, by excluding the prosthetic device, affecting the treatment, loosing patient's time, doctor's time, implying the dental laboratory and extra expenses. The causes of fractures are many, from clinical cases with some specific anatomic and functional particularities, or parafunctional, to the incorrect designing, manufacturing or wearing of the prosthetic part, being connected with the materials characteristics. The consequences and costs of these fractures are leading to unsatisfying results in some of the clinical cases, in presence of parafunctions like bruxism or clenching and specifically for the new types of prosthetic rehabilitation, on natural teeth or implants.

Remote transient Lactobacillus animalis bacteremia causing prosthetic hip joint infection: a case report.

PubMed

Somayaji, R; Lynch, T; Powell, J N; Gregson, D

2016-11-04

Lactobacillus spp. are uncommon pathogens in immunocompetent hosts, and even rarer causes of prosthetic device infections. A case of chronic hip prosthetic joint infection (PJI) caused by L. animalis is described. This occurred 5 years after a transient bacteremia with the same organism. Whole genome sequencing of both isolates proved this PJI infection resulted from this remote bacteremia. We document that prosthetic joint infections may be a consequence of bacteremia as much as 3 years before the onset of symptoms.

Cataract, cost: curious questions.

PubMed

Moran, D J

1999-02-01

An investigation of the pricing of implantable prosthetic devices in Australia reveals some alarming practices. A governmental mechanism exists to prop up the pricing of 7500 listed devices to levels that are unacceptably high by world standards. Private hospitals and doctors are able, legally, to profit by marking up the cost of these devices from the market price to this artificially inflated price. Even the open market prices of implantable prosthetic items, such as intra-ocular lenses, are high by international standards. In a time of budgetary constraint for health spending and rapidly increasing use of these devices, these issues urgently need to be addressed in Australia.

The use of a direct manufacturing prosthetic socket system in a rural community in South Africa: A pilot study and lessons for future research.

PubMed

Ennion, Liezel; Johannesson, Anton; Rhoda, Anthea

2017-10-01

Challenges exist with the provision of appropriate mobility assistive devices in rural areas. The use of the direct manufacturing prosthetic socket system is a possible solution to these challenges. The objective of this study was to test and explore the clients' perspectives with the application of this device. Within a mixed-methods approach, a longitudinal sequential explanatory design was applied. The Orthotic and Prosthetic User's Survey was administered to explore the use of the direct manufacturing prosthetic socket system in terms of function, health-related quality of life and client satisfaction. A conveniently selected sample of 21 individuals who suffered a unilateral trans-tibial amputation was included. Data were collected at 1, 3 and 6 months post fitting, and two focus group discussions were also administered. Of the 21 participants recruited, 11 returned for follow up. Although participants reported favourably about the prosthesis, their scores were generally worse than the norms with regard to function and quality of life. Participants highlighted the need for improvement in the cosmetic appearance of the prosthesis. The direct manufacturing prosthetic socket system could be considered as an alternative technique of socket manufacturing for individuals living in rural areas due to the shorter manufacture time and promising initial results, but further research on this topic with a bigger sample is recommended. Clinical relevance The direct manufacturing prosthetic socket system may be considered as an alternative to the traditional prosthetic socket manufacturing technique used in South Africa. As this device requires only one visit and therefore decreased travel by the patients to the hospitals, it could be applicable to more amputees who cannot return to hospital post discharge.

First-in-man demonstration of a fully implanted myoelectric sensors system to control an advanced electromechanical prosthetic hand.

PubMed

Pasquina, Paul F; Evangelista, Melissa; Carvalho, A J; Lockhart, Joseph; Griffin, Sarah; Nanos, George; McKay, Patricia; Hansen, Morten; Ipsen, Derek; Vandersea, James; Butkus, Josef; Miller, Matthew; Murphy, Ian; Hankin, David

2015-04-15

Advanced motorized prosthetic devices are currently controlled by EMG signals generated by residual muscles and recorded by surface electrodes on the skin. These surface recordings are often inconsistent and unreliable, leading to high prosthetic abandonment rates for individuals with upper limb amputation. Surface electrodes are limited because of poor skin contact, socket rotation, residual limb sweating, and their ability to only record signals from superficial muscles, whose function frequently does not relate to the intended prosthetic function. More sophisticated prosthetic devices require a stable and reliable interface between the user and robotic hand to improve upper limb prosthetic function. Implantable Myoelectric Sensors (IMES(®)) are small electrodes intended to detect and wirelessly transmit EMG signals to an electromechanical prosthetic hand via an electro-magnetic coil built into the prosthetic socket. This system is designed to simultaneously capture EMG signals from multiple residual limb muscles, allowing the natural control of multiple degrees of freedom simultaneously. We report the status of the first FDA-approved clinical trial of the IMES(®) System. This study is currently in progress, limiting reporting to only preliminary results. Our first subject has reported the ability to accomplish a greater variety and complexity of tasks in his everyday life compared to what could be achieved with his previous myoelectric prosthesis. The interim results of this study indicate the feasibility of utilizing IMES(®) technology to reliably sense and wirelessly transmit EMG signals from residual muscles to intuitively control a three degree-of-freedom prosthetic arm. Copyright © 2014 Elsevier B.V. All rights reserved.

Circuit For Control Of Electromechanical Prosthetic Hand

NASA Technical Reports Server (NTRS)

Bozeman, Richard J., Jr.

1995-01-01

Proposed circuit for control of electromechanical prosthetic hand derives electrical control signals from shoulder movements. Updated, electronic version of prosthesis, that includes two hooklike fingers actuated via cables from shoulder harness. Circuit built around favored shoulder harness, provides more dexterous movement, without incurring complexity of computer-controlled "bionic" or hydraulically actuated devices. Additional harness and potentiometer connected to similar control circuit mounted on other shoulder. Used to control stepping motor rotating hand about prosthetic wrist to one of number of angles consistent with number of digital outputs. Finger-control signals developed by circuit connected to first shoulder harness transmitted to prosthetic hand via sliprings at prosthetic wrist joint.

Development of a Prosthesis for Urinary Control

NASA Technical Reports Server (NTRS)

Tenney, J. B.; Rabinowitz, R.; Tomkiewicz, Z.; Harrison, H. N.; Rogers, D. W.

1986-01-01

Report describes development and marketing of prosthetic sphincter for urinary control. With prosthetic device, patients void bladder every 3 to 4 hours. Periodic voiding keeps bladder muscles exercised and healthy and avoids bladder infections and kidney damage.

A new three-dimensional, print-on-demand temporomandibular prosthetic total joint replacement system: Preliminary outcomes.

PubMed

Dimitroulis, George; Austin, Stephen; Sin Lee, Peter Vee; Ackland, David

2018-05-16

The aim of this study is to present the preliminary clinical data on the OMX Temporomandibular Joint (TMJ) Prosthetic total joint replacement system. A prospective, cohort, clinical study was undertaken of consecutive adult patients with Category 5 end-stage joint disease who were implanted with the OMX TMJ prosthesis between May 2015 and April 2017. A total of 50 devices were implanted in 38 patients, with 12 patients receiving bilateral prosthetic joints. There were 31 females and 7 males in this cohort, who ranged in age from 20 to 66 years, with a mean of 43.8 years (±14.0 years). Ten of the 50 prosthetic joints (20%) were fully customized, while the remaining were patient matched using virtual planning software. Based on a mean follow-up period of 15.3 months (range 12-24 months) following the TMJ total joint replacement, preliminary results suggest the OMX TMJ prosthesis has made a positive impact on clinical outcomes, with a mean 74.4% reduction in joint pain levels and significant improvements (p < 0.05) in jaw function as measured by the visual analogue scales for mouth opening (30.8%), diet (77.1%), and function (59.2%). No device failures were reported during the study period. This study suggests that the print-on-demand OMX TMJ prosthesis, designed for rapid delivery of both patient-matched and fully customize devices, represents a safe, reliable and versatile implantable joint replacement system for the treatment of category 5 end-stage TMJ disease. Copyright © 2018 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Assessment of Myoelectric Controller Performance and Kinematic Behavior of a Novel Soft Synergy-Inspired Robotic Hand for Prosthetic Applications

PubMed Central

Fani, Simone; Bianchi, Matteo; Jain, Sonal; Pimenta Neto, José Simões; Boege, Scott; Grioli, Giorgio; Bicchi, Antonio; Santello, Marco

2016-01-01

Myoelectric artificial limbs can significantly advance the state of the art in prosthetics, since they can be used to control mechatronic devices through muscular activity in a way that mimics how the subjects used to activate their muscles before limb loss. However, surveys indicate that dissatisfaction with the functionality of terminal devices underlies the widespread abandonment of prostheses. We believe that one key factor to improve acceptability of prosthetic devices is to attain human likeness of prosthesis movements, a goal which is being pursued by research on social and human–robot interactions. Therefore, to reduce early abandonment of terminal devices, we propose that controllers should be designed so as to ensure effective task accomplishment in a natural fashion. In this work, we have analyzed and compared the performance of three types of myoelectric controller algorithms based on surface electromyography to control an underactuated and multi-degrees of freedom prosthetic hand, the SoftHand Pro. The goal of the present study was to identify the myoelectric algorithm that best mimics the native hand movements. As a preliminary step, we first quantified the repeatability of the SoftHand Pro finger movements and identified the electromyographic recording sites for able-bodied individuals with the highest signal-to-noise ratio from two pairs of muscles, i.e., flexor digitorum superficialis/extensor digitorum communis, and flexor carpi radialis/extensor carpi ulnaris. Able-bodied volunteers were then asked to execute reach-to-grasp movements, while electromyography signals were recorded from flexor digitorum superficialis/extensor digitorum communis as this was identified as the muscle pair characterized by high signal-to-noise ratio and intuitive control. Subsequently, we tested three myoelectric controllers that mapped electromyography signals to position of the SoftHand Pro. We found that a differential electromyography-to-position mapping ensured the highest coherence with hand movements. Our results represent a first step toward a more effective and intuitive control of myoelectric hand prostheses. PMID:27799908

21 CFR 872.3140 - Resin applicator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3140 Resin applicator. (a) Identification. A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of...

New horizons for orthotic and prosthetic technology: artificial muscle for ambulation

NASA Astrophysics Data System (ADS)

Herr, Hugh M.; Kornbluh, Roy D.

2004-07-01

The rehabilitation community is at the threshold of a new age in which orthotic and prosthetic devices will no longer be separate, lifeless mechanisms, but intimate extensions of the human body-structurally, neurologically, and dynamically. In this paper we discuss scientific and technological advances that promise to accelerate the merging of body and machine, including the development of actuator technologies that behave like muscle and control methodologies that exploit principles of biological movement. We present a state-of-the-art device for leg rehabilitation: a powered ankle-foot orthosis for stroke, cerebral palsy, or multiple sclerosis patients. The device employs a forcecontrollable actuator and a biomimetic control scheme that automatically modulates ankle impedance and motive torque to satisfy patient-specific gait requirements. Although the device has some clinical benefits, problems still remain. The force-controllable actuator comprises an electric motor and a mechanical transmission, resulting in a heavy, bulky, and noisy mechanism. As a resolution of this difficulty, we argue that electroactive polymer-based artificial muscle technologies may offer considerable advantages to the physically challenged, allowing for joint impedance and motive force controllability, noise-free operation, and anthropomorphic device morphologies.

Committing to Memory: Memory Prosthetics Show Promise in Helping Those with Neurodegenerative Disorders.

PubMed

Solis, Michele

2017-01-01

Cell phone chimes, sticky notes, even the proverbial string around a finger-these timehonored external cues help guard against our inevitable memory lapses. But some internal help to the brain itself may be on the way in the form of what's being called memory prosthetics. Once considered to be on the fringes of neuroscience, the idea of adding hardware to the brain to help with memory has gathered steam. In 2014, the U.S. Defense Advanced Research Projects Agency (DARPA) made a US$30 million investment in memory prosthetic research as part of the Obama administration's Brain Research through Advancing Innovative Neurotechnologies initiative. In August 2016, Kernel, a startup based in Los Angeles, California, announced its goal to develop a clinical memory device for those debilitated by neurodegenerative disorders such as Alzheimer's disease.

CAD/CAM fabricated complete dentures: concepts and clinical methods of obtaining required morphological data.

PubMed

Goodacre, Charles J; Garbacea, Antoanela; Naylor, W Patrick; Daher, Tony; Marchack, Christopher B; Lowry, Jean

2012-01-01

The clinical impression procedures described in this article provide a method of recording the morphology of the intaglio and cameo surfaces of complete denture bases and also identify muscular and phonetic locations for the prosthetic teeth. When the CAD/CAM technology for fabricating complete dentures becomes commercially available, it will be possible to scan the denture base morphology and tooth positions recorded with this technique and import those data into a virtual tooth arrangement program where teeth can be articulated and then export the data to a milling device for the fabrication of the complete dentures. A prototype 3-D tooth arrangement program is described in this article that serves as an example of the type of program than can be used to arrange prosthetic teeth virtually as part of the overall CAD/CAM fabrication of complete dentures. Copyright © 2012 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

Bar-holding prosthetic limb

NASA Technical Reports Server (NTRS)

Vest, Thomas W. (Inventor); Norton, William E. (Inventor); Belcher, Jewell G. (Inventor); Carden, James R. (Inventor)

1992-01-01

A prosthetic device for below-the-elbow amputees is disclosed. The device has a removable effector, which is attached to the end of an arm cuff. The effector is comprised of a pair of C-shaped members that are oriented so as to face each other. Working in concert, the C-shaped members are able to hold a bar such as a chainsaw handle. A flat spring is fitted around the C-shaped members to hold them together.

Evolution of penile prosthetic devices

PubMed Central

Burnett, Arthur L.

2015-01-01

Penile implant usage dates to the 16th century yet penile implants to treat erectile dysfunction did not occur until nearly four centuries later. The modern era of penile implants has progressed rapidly over the past 50 years as physicians' knowledge of effective materials for penile prostheses and surgical techniques has improved. Herein, we describe the history of penile prosthetics and the constant quest to improve the technology. Elements of the design from the first inflatable penile prosthesis by Scott and colleagues and the Small-Carrion malleable penile prosthesis are still found in present iterations of these devices. While there have been significant improvements in penile prosthesis design, the promise of an ideal prosthetic device remains elusive. As other erectile dysfunction therapies emerge, penile prostheses will have to continue to demonstrate a competitive advantage. A particular strength of penile prostheses is their efficacy regardless of etiology, thus allowing treatment of even the most refractory cases. PMID:25763121

Evolution of penile prosthetic devices.

PubMed

Le, Brian; Burnett, Arthur L

2015-03-01

Penile implant usage dates to the 16th century yet penile implants to treat erectile dysfunction did not occur until nearly four centuries later. The modern era of penile implants has progressed rapidly over the past 50 years as physicians' knowledge of effective materials for penile prostheses and surgical techniques has improved. Herein, we describe the history of penile prosthetics and the constant quest to improve the technology. Elements of the design from the first inflatable penile prosthesis by Scott and colleagues and the Small-Carrion malleable penile prosthesis are still found in present iterations of these devices. While there have been significant improvements in penile prosthesis design, the promise of an ideal prosthetic device remains elusive. As other erectile dysfunction therapies emerge, penile prostheses will have to continue to demonstrate a competitive advantage. A particular strength of penile prostheses is their efficacy regardless of etiology, thus allowing treatment of even the most refractory cases.

Development of regenerative peripheral nerve interfaces for motor control of neuroprosthetic devices

NASA Astrophysics Data System (ADS)

Kemp, Stephen W. P.; Urbanchek, Melanie G.; Irwin, Zachary T.; Chestek, Cynthia A.; Cederna, Paul S.

2017-05-01

Traumatic peripheral nerve injuries suffered during amputation commonly results in debilitating neuropathic pain in the affected limb. Modern prosthetic technologies allow for intuitive, simultaneous control of multiple degrees of freedom. However, these state-of-the-art devices require separate, independent control signals for each degree of freedom, which is currently not possible. As a result, amputees reject up to 75% of myoelectric devices preferring instead to use body-powered artificial limbs which offer subtle sensory feedback. Without meaningful and intuitive sensory feedback, even the most advanced myoelectric prostheses remain insensate, burdensome, and are associated with enormous cognitive demand and mental fatigue. The ideal prosthetic device is one which is capable of providing intuitive somatosensory feedback essential for interaction with the environment. Critical to the design of such a bioprosthetic device is the development of a reliable biologic interface between human and machine. This ideal patient-prosthetic interface allows for transmission of both afferent somatosensory information and efferent motor signals for a closed-loop feedback system of neural control. Our lab has developed the Regenerative Peripheral Nerve Interface (RPNI) as a biologic nerve interface designed for stable integration of a prosthetic device with transected peripheral nerves in a residual limb. The RPNI is constructed by surgically implanting the distal end of a transected peripheral nerve into an autogenous muscle graft. Animal experiments in our lab have shown recording of motor signals from RPNI's implanted into both rodents and monkeys. Here, we achieve high amplitude EMG signals with a high signal to noise (SNR) ratio.

Can We Achieve Intuitive Prosthetic Elbow Control Based on Healthy Upper Limb Motor Strategies?

PubMed Central

Merad, Manelle; de Montalivet, Étienne; Touillet, Amélie; Martinet, Noël; Roby-Brami, Agnès; Jarrassé, Nathanaël

2018-01-01

Most transhumeral amputees report that their prosthetic device lacks functionality, citing the control strategy as a major limitation. Indeed, they are required to control several degrees of freedom with muscle groups primarily used for elbow actuation. As a result, most of them choose to have a one-degree-of-freedom myoelectric hand for grasping objects, a myoelectric wrist for pronation/supination, and a body-powered elbow. Unlike healthy upper limb movements, the prosthetic elbow joint angle, adjusted prior to the motion, is not involved in the overall upper limb movements, causing the rest of the body to compensate for the lack of mobility of the prosthesis. A promising solution to improve upper limb prosthesis control exploits the residual limb mobility: like in healthy movements, shoulder and prosthetic elbow motions are coupled using inter-joint coordination models. The present study aims to test this approach. A transhumeral amputated individual used a prosthesis with a residual limb motion-driven elbow to point at targets. The prosthetic elbow motion was derived from IMU-based shoulder measurements and a generic model of inter-joint coordinations built from healthy individuals data. For comparison, the participant also performed the task while the prosthetic elbow was implemented with his own myoelectric control strategy. The results show that although the transhumeral amputated participant achieved the pointing task with a better precision when the elbow was myoelectrically-controlled, he had to develop large compensatory trunk movements. Automatic elbow control reduced trunk displacements, and enabled a more natural body behavior with synchronous shoulder and elbow motions. However, due to socket impairments, the residual limb amplitudes were not as large as those of healthy shoulder movements. Therefore, this work also investigates if a control strategy whereby prosthetic joints are automatized according to healthy individuals' coordination models can lead to an intuitive and natural prosthetic control. PMID:29456499

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.

21 CFR 872.3060 - Noble metal alloy.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3060 Noble metal alloy. (a) Identification. A noble metal... “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the...

21 CFR 890.3665 - Congenital hip dislocation abduction splint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890... abduction splint is a device intended for medical purposes to stabilize the hips of a young child with...

First-in-Man Demonstration of Fully Implanted Myoelectric Sensors for Control of an Advanced Electromechanical Arm by Transradial Amputees

PubMed Central

Pasquina, Paul F.; Evangelista, Melissa; Carvalho, Antonio J.; Lockhart, Joseph; Griffin, Sarah; Nanos, George; McKay, Patricia; Hansen, Morten; Ipsen, Derek; Vandersea, James; Butkus, Josef; Miller, Matthew; Murphy, Ian; Hankin, David

2014-01-01

Background Advanced motorized prosthetic devices are currently controlled by EMG signals generated by residual muscles and recorded by surface electrodes on the skin. These surface recordings are often inconsistent and unreliable, leading to high prosthetic abandonment rates for individuals with upper limb amputation. Surface electrodes are limited because of poor skin contact, socket rotation, residual limb sweating, and their ability to only record signals from superficial muscles, whose function frequently does not relate to the intended prosthetic function. More sophisticated prosthetic devices require a stable and reliable interface between the user and robotic hand to improve upper limb prosthetic function. New Method Implantable Myoelectric Sensors (IMES®) are small electrodes intended to detect and wirelessly transmit EMG signals to an electromechanical prosthetic hand via an electromagnetic coil built into the prosthetic socket. This system is designed to simultaneously capture EMG signals from multiple residual limb muscles, allowing the natural control of multiple degrees of freedom simultaneously. Results We report the status of the first FDA-approved clinical trial of the IMES® System. This study is currently in progress, limiting reporting to only preliminary results. Comparison with Existing Methods Our first subject has reported the ability to accomplish a greater variety and complexity of tasks in his everyday life compared to what could be achieved with his previous myoelectric prosthesis. Conclusion The interim results of this study indicate the feasibility of utilizing IMES® technology to reliably sense and wirelessly transmit EMG signals from residual muscles to intuitively control a three degree-of-freedom prosthetic arm. PMID:25102286

Rotational joint for prosthetic leg

NASA Technical Reports Server (NTRS)

Jones, W. C.; Owens, L. J.

1977-01-01

Device is installed in standard 30 millimeter tubing used for lower leg prosthetics. Unit allows proper rotation (about 3 degrees) of foot relative to the hip, during normal walking or running. Limited rotational movement with restoring force results in a more natural gait.

Control of non-linear actuator of artificial muscles for the use in low-cost robotics prosthetics limbs

NASA Astrophysics Data System (ADS)

Anis Atikah, Nurul; Yeng Weng, Leong; Anuar, Adzly; Chien Fat, Chau; Sahari, Khairul Salleh Mohamed; Zainal Abidin, Izham

2017-10-01

Currently, the methods of actuating robotic-based prosthetic limbs are moving away from bulky actuators to more fluid materials such as artificial muscles. The main disadvantages of these artificial muscles are their high cost of manufacturing, low-force generation, cumbersome and complex controls. A recent discovery into using super coiled polymer (SCP) proved to have low manufacturing costs, high force generation, compact and simple controls. Nevertheless, the non-linear controls still exists due to the nature of heat-based actuation, which is hysteresis. This makes position control difficult. Using electrically conductive devices allows for very quick heating, but not quick cooling. This research tries to solve the problem by using peltier devices, which can effectively heat and cool the SCP, hence giving way to a more precise control. The peltier device does not actively introduce more energy to a volume of space, which the coiled heating does; instead, it acts as a heat pump. Experiments were conducted to test the feasibility of using peltier as an actuating method on different diameters of nylon fishing strings. Based on these experiments, the performance characteristics of the strings were plotted, which could be used to control the actuation of the string efficiently in the future.

21 CFR 872.3130 - Preformed anchor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3130 Preformed anchor. (a) Identification. A preformed... the platinum group intended to be incorporated into a dental appliance, such as a denture, to help...

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic... consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning...

21 CFR 890.3675 - Denis Brown splint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3675 Denis Brown splint. (a... on young children with tibial torsion (excessive rotation of the lower leg) or club foot. (b...

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic... consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning...

21 CFR 872.3080 - Mercury and alloy dispenser.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3080 Mercury and alloy dispenser. (a... dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured...

21 CFR 872.3850 - Gutta percha.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DENTAL DEVICES Prosthetic Devices § 872.3850 Gutta percha. (a) Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The...

21 CFR 872.3765 - Pit and fissure sealant and conditioner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3765 Pit and fissure sealant and... depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. (b) Classification...

21 CFR 872.3765 - Pit and fissure sealant and conditioner.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3765 Pit and fissure sealant and... depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. (b) Classification...

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...

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...

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...

Simulated Prosthetic Vision: The Benefits of Computer-Based Object Recognition and Localization.

PubMed

Macé, Marc J-M; Guivarch, Valérian; Denis, Grégoire; Jouffrais, Christophe

2015-07-01

Clinical trials with blind patients implanted with a visual neuroprosthesis showed that even the simplest tasks were difficult to perform with the limited vision restored with current implants. Simulated prosthetic vision (SPV) is a powerful tool to investigate the putative functions of the upcoming generations of visual neuroprostheses. Recent studies based on SPV showed that several generations of implants will be required before usable vision is restored. However, none of these studies relied on advanced image processing. High-level image processing could significantly reduce the amount of information required to perform visual tasks and help restore visuomotor behaviors, even with current low-resolution implants. In this study, we simulated a prosthetic vision device based on object localization in the scene. We evaluated the usability of this device for object recognition, localization, and reaching. We showed that a very low number of electrodes (e.g., nine) are sufficient to restore visually guided reaching movements with fair timing (10 s) and high accuracy. In addition, performance, both in terms of accuracy and speed, was comparable with 9 and 100 electrodes. Extraction of high level information (object recognition and localization) from video images could drastically enhance the usability of current visual neuroprosthesis. We suggest that this method-that is, localization of targets of interest in the scene-may restore various visuomotor behaviors. This method could prove functional on current low-resolution implants. The main limitation resides in the reliability of the vision algorithms, which are improving rapidly. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Rotational joint assembly for the prosthetic leg

NASA Technical Reports Server (NTRS)

Owens, L. J.; Jones, W. C. (Inventor)

1977-01-01

A rotational joint assembly for a prosthetic leg has been devised, which enables an artificial foot to rotate slightly when a person is walking, running or turning. The prosthetic leg includes upper and lower tubular members with the rotational joint assembly interposed between them. The assembly includes a restrainer mechanism which consists of a pivotably mounted paddle element. This device applies limiting force to control the rotation of the foot and also restores torque to return the foot back to its initial position.

Development of nylon-based artificial muscles for the usage in robotic prosthetic limb

NASA Astrophysics Data System (ADS)

Atikah, Nurul Anis; Weng, Leong Yeng; Anuar, Adzly; Fat, Chau Chien; Abidin, Izham Zainal; Sahari, Khairul Salleh Mohamed

2017-09-01

This paper describes the development of nylon-based artificial muscles that is intended to be used in prosthetic limb for young amputees. Prosthetic limbs are very expensive and this situation is further compounded for young amputees who are very quickly out-grow their prosthesis. The proposed artificial muscles are made of nylon fishing strings from various size such as 0.45mm, 0.55mm, 0.65mm and 1.00mm. These fishing strings were twisted into coils to create Super Coiled Polymers (SCP) and tested using hot air blower. These artificial muscles react counterintuitively, where when it is exposed to heat, contracts, and when cooled, expands. Peltier devices, when switched-on acts as heat pump, where one side is hot and the other is cold. This phenomenon, when affixed in between 2 SCP's, creates tandem motion similar to triceps and biceps. As initial study, the hot side of the Peltier module was tested using these artificial muscles. The string was measured for both its force production, length contraction, the initial results were promising.

Robotic hand with locking mechanism using TCP muscles for applications in prosthetic hand and humanoids

NASA Astrophysics Data System (ADS)

Saharan, Lokesh; Tadesse, Yonas

2016-04-01

This paper presents a biomimetic, lightweight, 3D printed and customizable robotic hand with locking mechanism consisting of Twisted and Coiled Polymer (TCP) muscles based on nylon precursor fibers as artificial muscles. Previously, we have presented a small-sized biomimetic hand using nylon based artificial muscles and fishing line muscles as actuators. The current study focuses on an adult-sized prosthetic hand with improved design and a position/force locking system. Energy efficiency is always a matter of concern to make compact, lightweight, durable and cost effective devices. In natural human hand, if we keep holding objects for long time, we get tired because of continuous use of energy for keeping the fingers in certain positions. Similarly, in prosthetic hands we also need to provide energy continuously to artificial muscles to hold the object for a certain period of time, which is certainly not energy efficient. In this work we, describe the design of the robotic hand and locking mechanism along with the experimental results on the performance of the locking mechanism.

42 CFR 414.226 - Oxygen and oxygen equipment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 3 2011-10-01 2011-10-01 false Oxygen and oxygen equipment. 414.226 Section 414... Equipment and Prosthetic and Orthotic Devices § 414.226 Oxygen and oxygen equipment. (a) Payment rules—(1) Oxygen equipment. Payment for rental of oxygen equipment is made based on a monthly fee schedule amount...

42 CFR 414.226 - Oxygen and oxygen equipment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Oxygen and oxygen equipment. 414.226 Section 414... Equipment and Prosthetic and Orthotic Devices § 414.226 Oxygen and oxygen equipment. (a) Payment rules—(1) Oxygen equipment. Payment for rental of oxygen equipment is made based on a monthly fee schedule amount...

42 CFR 414.226 - Oxygen and oxygen equipment.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 3 2012-10-01 2012-10-01 false Oxygen and oxygen equipment. 414.226 Section 414... Durable Medical Equipment and Prosthetic and Orthotic Devices § 414.226 Oxygen and oxygen equipment. (a) Payment rules—(1) Oxygen equipment. Payment for rental of oxygen equipment is made based on a monthly fee...

42 CFR 414.226 - Oxygen and oxygen equipment.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 3 2013-10-01 2013-10-01 false Oxygen and oxygen equipment. 414.226 Section 414... Durable Medical Equipment and Prosthetic and Orthotic Devices § 414.226 Oxygen and oxygen equipment. (a) Payment rules—(1) Oxygen equipment. Payment for rental of oxygen equipment is made based on a monthly fee...

SU-E-T-512: Evaluation of Treatment Planning Dose Calculation Accuracy at the Interface of Prosthetic Devices.

PubMed

Paulu, D; Alaei, P

2012-06-01

To evaluate the ability of treatment planning algorithm to accurately predict dose delivered at the interface of high density implanted devices. A high density (7.6 g/cc) Cobalt-Chromium-Molybdenum hip prosthesis was molded into an epoxy-based cylindrical leg phantom. The phantom was designed to be separated in half to access the prosthesis and to place the TLDs. Using MVCT to image the apparatus, a simple treatment plan was developed using the Philips Pinnacle treatment planning system. Wires were placed in the molded epoxy to allow for accurate definition of measurement sites (TLD positions) along the surface of the prosthesis. Micro-cube TLDs (1 mm 3 ) were placed at six measurement locations for which the dose had been calculated by the treatment planning system. An Elekta Synergy linear accelerator was used to deliver a 400 cGy plan to the phantom with 6 MV photons in a single fraction. A total of four 10 cm × 21 cm fields were used at 0, 90, 180, and 270 degree gantry rotations. Initial results indicate that the measured dose is 7-17% lower than the dose calculated by the treatment planning system. Further study using high energy beams are also in progress. Initial results indicate that the treatment planning system does predict the dose near a high density prosthetic device within 10-15% but underestimates the dose. The results of this study could help in designing treatment plans which would reduce the uncertainty of the dose delivered in the vicinity of prosthetic hip implants and similar devices. © 2012 American Association of Physicists in Medicine.

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...

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...

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...

A dynamic model-based approach to motion and deformation tracking of prosthetic valves from biplane x-ray images.

PubMed

Wagner, Martin G; Hatt, Charles R; Dunkerley, David A P; Bodart, Lindsay E; Raval, Amish N; Speidel, Michael A

2018-04-16

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure in which a prosthetic heart valve is placed and expanded within a defective aortic valve. The device placement is commonly performed using two-dimensional (2D) fluoroscopic imaging. Within this work, we propose a novel technique to track the motion and deformation of the prosthetic valve in three dimensions based on biplane fluoroscopic image sequences. The tracking approach uses a parameterized point cloud model of the valve stent which can undergo rigid three-dimensional (3D) transformation and different modes of expansion. Rigid elements of the model are individually rotated and translated in three dimensions to approximate the motions of the stent. Tracking is performed using an iterative 2D-3D registration procedure which estimates the model parameters by minimizing the mean-squared image values at the positions of the forward-projected model points. Additionally, an initialization technique is proposed, which locates clusters of salient features to determine the initial position and orientation of the model. The proposed algorithms were evaluated based on simulations using a digital 4D CT phantom as well as experimentally acquired images of a prosthetic valve inside a chest phantom with anatomical background features. The target registration error was 0.12 ± 0.04 mm in the simulations and 0.64 ± 0.09 mm in the experimental data. The proposed algorithm could be used to generate 3D visualization of the prosthetic valve from two projections. In combination with soft-tissue sensitive-imaging techniques like transesophageal echocardiography, this technique could enable 3D image guidance during TAVR procedures. © 2018 American Association of Physicists in Medicine.

Federal regulation of vision enhancement devices for normal and abnormal vision

NASA Astrophysics Data System (ADS)

Drum, Bruce

2006-09-01

The Food and Drug Administration (FDA) evaluates the safety and effectiveness of medical devices and biological products as well as food and drugs. The FDA defines a device as a product that is intended, by physical means, to diagnose, treat, or prevent disease, or to affect the structure or function of the body. All vision enhancement devices fulfill this definition because they are intended to affect a function (vision) of the body. In practice, however, FDA historically has drawn a distinction between devices that are intended to enhance low vision as opposed to normal vision. Most low vision aids are therapeutic devices intended to compensate for visual impairment, and are actively regulated according to their level of risk to the patient. The risk level is usually low (e.g. Class I, exempt from 510(k) submission requirements for magnifiers that do not touch the eye), but can be as high as Class III (requiring a clinical trial and Premarket Approval (PMA) application) for certain implanted and prosthetic devices (e.g. intraocular telescopes and prosthetic retinal implants). In contrast, the FDA usually does not actively enforce its regulations for devices that are intended to enhance normal vision, are low risk, and do not have a medical intended use. However, if an implanted or prosthetic device were developed for enhancing normal vision, the FDA would likely decide to regulate it actively, because its intended use would entail a substantial medical risk to the user. Companies developing such devices should contact the FDA at an early stage to clarify their regulatory status.

21 CFR 878.3300 - Surgical mesh.

Code of Federal Regulations, 2012 CFR

2012-04-01

... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

21 CFR 878.3300 - Surgical mesh.

Code of Federal Regulations, 2014 CFR

2014-04-01

... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

21 CFR 878.3300 - Surgical mesh.

Code of Federal Regulations, 2010 CFR

2010-04-01

... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

21 CFR 878.3300 - Surgical mesh.

Code of Federal Regulations, 2013 CFR

2013-04-01

... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

21 CFR 878.3300 - Surgical mesh.

Code of Federal Regulations, 2011 CFR

2011-04-01

... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

21 CFR 872.3980 - Endosseous dental implant accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

Prosthetic metal implants and airport metal detectors.

PubMed

Ismail, A; Dancey, A; Titley, O G

2013-04-01

Metal detectors have been present in airports and points of departure for some time. With the introduction of heightened security measures in response to fears of an increased threat of terrorism, they may become more prevalent in other public locations. The aim of this study was to ascertain which prosthetic devices activated metal detector devices used for security purposes. A range of prosthetic devices used commonly in orthopaedic and plastic surgery procedures were passed through an arch metal detector at Birmingham Airport in the UK. Additionally, each item was passed under a wand detector. Items tested included expandable breast prostheses, plates used in wrist and hand surgery, screws, K-wires, Autosuture™ ligation clips and staples. No prostheses were detected by the arch detector. The expandable implants and wrist plates were the only devices detected by passing the wand directly over them. No device was detected by the wand when it was under cover of the axillary soft tissue. Screws, K-wires, Autosuture™ clips and staples were not detected under any of the study conditions. Although unlikely to trigger a detector, it is possible that an expandable breast prosthesis or larger plate may do so. It is therefore best to warn patients of this so they can anticipate detection and further examination.

Prosthetic metal implants and airport metal detectors

PubMed Central

Dancey, A; Titley, OG

2013-01-01

Introduction Metal detectors have been present in airports and points of departure for some time. With the introduction of heightened security measures in response to fears of an increased threat of terrorism, they may become more prevalent in other public locations. The aim of this study was to ascertain which prosthetic devices activated metal detector devices used for security purposes. Methods A range of prosthetic devices used commonly in orthopaedic and plastic surgery procedures were passed through an arch metal detector at Birmingham Airport in the UK. Additionally, each item was passed under a wand detector. Items tested included expandable breast prostheses, plates used in wrist and hand surgery, screws, K-wires, Autosuture™ ligation clips and staples. Results No prostheses were detected by the arch detector. The expandable implants and wrist plates were the only devices detected by passing the wand directly over them. No device was detected by the wand when it was under cover of the axillary soft tissue. Screws, K-wires, Autosuture™ clips and staples were not detected under any of the study conditions. Conclusions Although unlikely to trigger a detector, it is possible that an expandable breast prosthesis or larger plate may do so. It is therefore best to warn patients of this so they can anticipate detection and further examination. PMID:23827294

Emergence of a Stable Cortical Map for Neuroprosthetic Control

PubMed Central

Ganguly, Karunesh; Carmena, Jose M.

2009-01-01

Cortical control of neuroprosthetic devices is known to require neuronal adaptations. It remains unclear whether a stable cortical representation for prosthetic function can be stored and recalled in a manner that mimics our natural recall of motor skills. Especially in light of the mixed evidence for a stationary neuron-behavior relationship in cortical motor areas, understanding this relationship during long-term neuroprosthetic control can elucidate principles of neural plasticity as well as improve prosthetic function. Here, we paired stable recordings from ensembles of primary motor cortex neurons in macaque monkeys with a constant decoder that transforms neural activity to prosthetic movements. Proficient control was closely linked to the emergence of a surprisingly stable pattern of ensemble activity, indicating that the motor cortex can consolidate a neural representation for prosthetic control in the presence of a constant decoder. The importance of such a cortical map was evident in that small perturbations to either the size of the neural ensemble or to the decoder could reversibly disrupt function. Moreover, once a cortical map became consolidated, a second map could be learned and stored. Thus, long-term use of a neuroprosthetic device is associated with the formation of a cortical map for prosthetic function that is stable across time, readily recalled, resistant to interference, and resembles a putative memory engram. PMID:19621062

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...

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...

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...

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...

21 CFR 870.3460 - Endovascular Suturing System.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endovascular Suturing System. 870.3460 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular Suturing System. (a) Identification. An endovascular suturing system is a medical device intended to provide...

21 CFR 870.3460 - Endovascular Suturing System.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endovascular Suturing System. 870.3460 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular Suturing System. (a) Identification. An endovascular suturing system is a medical device intended to provide...

21 CFR 870.3460 - Endovascular Suturing System.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endovascular Suturing System. 870.3460 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3460 Endovascular Suturing System. (a) Identification. An endovascular suturing system is a medical device intended to provide...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3720 - Pacemaker electrode function tester.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker electrode function tester. 870.3720... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3720 Pacemaker electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3730 - Pacemaker service tools.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker service tools. 870.3730 Section 870.3730...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3730 Pacemaker service tools. (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker generator function analyzer. 870.3630... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker generator function analyzer. (a) Identification. A pacemaker generator function analyzer is a device that is...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 886.3340 - Extraocular orbital implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment...

21 CFR 872.3150 - Articulator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DENTAL DEVICES Prosthetic Devices § 872.3150 Articulator. (a) Identification. An articulator is a mechanical device intended to simulate movements of a patient's upper and lower jaws. Plaster casts of the patient's teeth and gums are placed in the device to reproduce the occlusion (bite) and articulation of...

Effects of a 3D segmental prosthetic system for tricuspid valve annulus remodelling on the right coronary artery: a human cadaveric coronary angiography study.

PubMed

Riki-Marishani, Mohsen; Gholoobi, Arash; Sazegar, Ghasem; Aazami, Mathias H; Hedjazi, Aria; Sajjadian, Maryam; Ebrahimi, Mahmoud; Aghaii-Zade Torabi, Ahmad

2017-09-01

A prosthetic system to repair secondary tricuspid valve regurgitation was developed. The conceptual engineering of the current device is based on 3D segmental remodelling of the tricuspid valve annulus in lieu of reductive annuloplasty. This study was designed to investigate the operational safety of the current prosthetic system with regard to the anatomical integrity of the right coronary artery (RCA) in fresh cadaveric human hearts. During the study period, from January to April 2016, the current prosthetic system was implanted on the tricuspid valve annulus in fresh cadaveric human hearts that met the study's inclusion criteria. The prepared specimens were investigated via selective coronary angiography of the RCA in the catheterization laboratory. The RCA angiographic anatomies were categorized as normal, distorted, kinked or occluded. Sixteen specimens underwent implantation of the current prosthetic system. The mean age of the cadaveric human hearts was 43.24 ± 15.79 years, with vehicle accident being the primary cause of death (59%). A dominant RCA was noticed in 62.5% of the specimens. None of the specimens displayed any injury, distortion, kinking or occlusion in the RCA due to the implantation of the prostheses. In light of the results of the present study, undertaken on fresh cadaveric human heart specimens, the current segmental prosthetic system for 3D remodelling of the tricuspid valve annulus seems to be safe vis-à-vis the anatomical integrity of the RCA. Further in vivo studies are needed to investigate the functional features of the current prosthetic system with a view to addressing the complex pathophysiology of secondary tricuspid valve regurgitation. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Design and evaluation of prosthetic shoulder controller

PubMed Central

Barton, Joseph E.; Sorkin, John D.

2015-01-01

We developed a 2-degree-of-freedom (DOF) shoulder position transducer (sensing shoulder protraction-retraction and elevation-depression) that can be used to control two of a powered prosthetic humerus' DOFs. We also developed an evaluation protocol based on Fitts' law to assess the performance of our device. The primary motivation for this work was to support development of powered prosthetic shoulder joints of a new generation of prosthetic arms for people with shoulder disarticulation and very high-level transhumeral amputation. We found that transducers that provided resistance to shoulder movement performed better than those providing no resistance. We also found that a position control scheme, where effector position is proportional to shoulder position, performed better than a velocity control scheme, where effector velocity is proportional to shoulder position. More generally, our transducer can be used to control motion along any two DOFs. It can also be used in a more general 4-DOF control scheme by sequentially controlling two DOFs at a time. The evaluation protocol has general applicability for researchers and practitioners. Researchers can employ it to compare different prosthesis designs and control schemes, while practitioners may find the evaluation protocol useful in evaluating and training people with amputation in the use of prostheses. PMID:25357185

Finite element analysis of the contact interface between trans-femoral stump and prosthetic socket.

PubMed

Zhang, Linlin; Zhu, Ming; Shen, Ling; Zheng, Feng

2013-01-01

Transfemoral amputees need prosthetic devices after amputation surgery, and the interface pressure between the residual limb and prosthetic socket has a significant effect on an amputee's satisfaction and comfort. The purpose of this study was to build a nonlinear finite element model to investigate the interface pressure between the above-knee residual limb and its prosthetic socket. The model was three-dimensional (3D) with consideration of nonlinear boundary conditions. Contact analysis was used to simulate the friction conditions between skin and the socket. The normal stresses up to 80.57 kPa at the distal end of the soft tissue. The longitudinal and circumferential shear stress distributions at the limb-socket interface were also simulated. This study explores the influences of load transfer between trans-femoral residual limb and its prosthetic socket.

A memory efficient implementation scheme of Gauss error function in a Laguerre-Volterra network for neuroprosthetic devices

NASA Astrophysics Data System (ADS)

Li, Will X. Y.; Cui, Ke; Zhang, Wei

2017-04-01

Cognitive neural prosthesis is a manmade device which can be used to restore or compensate for lost human cognitive modalities. The generalized Laguerre-Volterra (GLV) network serves as a robust mathematical underpinning for the development of such prosthetic instrument. In this paper, a hardware implementation scheme of Gauss error function for the GLV network targeting reconfigurable platforms is reported. Numerical approximations are formulated which transform the computation of nonelementary function into combinational operations of elementary functions, and memory-intensive look-up table (LUT) based approaches can therefore be circumvented. The computational precision can be made adjustable with the utilization of an error compensation scheme, which is proposed based on the experimental observation of the mathematical characteristics of the error trajectory. The precision can be further customizable by exploiting the run-time characteristics of the reconfigurable system. Compared to the polynomial expansion based implementation scheme, the utilization of slice LUTs, occupied slices, and DSP48E1s on a Xilinx XC6VLX240T field-programmable gate array has decreased by 94.2%, 94.1%, and 90.0%, respectively. While compared to the look-up table based scheme, 1.0 ×1017 bits of storage can be spared under the maximum allowable error of 1.0 ×10-3 . The proposed implementation scheme can be employed in the study of large-scale neural ensemble activity and in the design and development of neural prosthetic device.

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 872.3220 - Facebow.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Facebow. 872.3220 Section 872.3220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3220 Facebow. (a) Identification. A facebow is a device intended...

21 CFR 874.3375 - Battery-powered artificial larynx.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Battery-powered artificial larynx. 874.3375... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3375 Battery-powered artificial larynx. (a) Identification. A battery-powered artificial larynx is an externally applied device...

21 CFR 872.3660 - Impression material.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Impression material. 872.3660 Section 872.3660...) 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...

21 CFR 872.3660 - Impression material.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Impression material. 872.3660 Section 872.3660...) 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...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 888.3230 - Finger joint polymer constrained prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Finger joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3230 Finger joint polymer constrained prosthesis. (a) Identification. A finger joint polymer constrained prosthesis is a device intended...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food... DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable...

21 CFR 872.3940 - Total temporomandibular joint prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...

21 CFR 872.3940 - Total temporomandibular joint prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Total temporomandibular joint prosthesis. 872.3940... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be...

21 CFR 874.3375 - Battery-powered artificial larynx.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Battery-powered artificial larynx. 874.3375... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3375 Battery-powered artificial larynx. (a) Identification. A battery-powered artificial larynx is an externally applied device...

21 CFR 874.3375 - Battery-powered artificial larynx.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Battery-powered artificial larynx. 874.3375... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3375 Battery-powered artificial larynx. (a) Identification. A battery-powered artificial larynx is an externally applied device...

21 CFR 874.3375 - Battery-powered artificial larynx.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Battery-powered artificial larynx. 874.3375... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3375 Battery-powered artificial larynx. (a) Identification. A battery-powered artificial larynx is an externally applied device...

21 CFR 874.3375 - Battery-powered artificial larynx.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Battery-powered artificial larynx. 874.3375... (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3375 Battery-powered artificial larynx. (a) Identification. A battery-powered artificial larynx is an externally applied device...

Brachial plexus injury management through upper extremity amputation with immediate postoperative prostheses.

PubMed

Malone, J M; Leal, J M; Underwood, J; Childers, S J

1982-02-01

Management of patients with brachial plexus injuries requires a team approach so that all aspects of their care are addressed simultaneously. This report examines elective amputation and prosthetic rehabilitation in a patient with brachial plexus avulsion of the left arm. The best possibility for good prosthetic rehabilitation is the early application of prosthetic devices with intensive occupational therapy. Using this type of approach, we have achieved significant improvement in amputation rehabilitation of upper extremity amputees treated with immediate postoperative conventional electric and myoelectric prostheses.

Doppler ultrasound-based measurement of tendon velocity and displacement for application toward detecting user-intended motion.

PubMed

Stegman, Kelly J; Park, Edward J; Dechev, Nikolai

2012-07-01

The motivation of this research is to non-invasively monitor the wrist tendon's displacement and velocity, for purposes of controlling a prosthetic device. This feasibility study aims to determine if the proposed technique using Doppler ultrasound is able to accurately estimate the tendon's instantaneous velocity and displacement. This study is conducted with a tendon mimicking experiment consisting of two different materials: a commercial ultrasound scanner, and a reference linear motion stage set-up. Audio-based output signals are acquired from the ultrasound scanner, and are processed with our proposed Fourier technique to obtain the tendon's velocity and displacement estimates. We then compare our estimates to an external reference system, and also to the ultrasound scanner's own estimates based on its proprietary software. The proposed tendon motion estimation method has been shown to be repeatable, effective and accurate in comparison to the external reference system, and is generally more accurate than the scanner's own estimates. After establishing this feasibility study, future testing will include cadaver-based studies to test the technique on the human arm tendon anatomy, and later on live human test subjects in order to further refine the proposed method for the novel purpose of detecting user-intended tendon motion for controlling wearable prosthetic devices.

21 CFR 886.3600 - Intraocular lens.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intraocular lens. 886.3600 Section 886.3600 Food... DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3600 Intraocular lens. (a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace...

21 CFR 872.3661 - Optical Impression Systems for CAD/CAM.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3661 Optical Impression Systems for CAD... (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3010 - Bone fixation cerclage.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Bone fixation cerclage. 888.3010 Section 888.3010...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3010 Bone fixation cerclage. (a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as...

21 CFR 888.3015 - Bone heterograft.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Bone heterograft. 888.3015 Section 888.3015 Food... DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3015 Bone heterograft. (a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to...

21 CFR 888.3015 - Bone heterograft.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Bone heterograft. 888.3015 Section 888.3015 Food... DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3015 Bone heterograft. (a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to...

21 CFR 888.3010 - Bone fixation cerclage.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone fixation cerclage. 888.3010 Section 888.3010...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3010 Bone fixation cerclage. (a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as...

21 CFR 888.3010 - Bone fixation cerclage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Bone fixation cerclage. 888.3010 Section 888.3010...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3010 Bone fixation cerclage. (a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as...

21 CFR 888.3010 - Bone fixation cerclage.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Bone fixation cerclage. 888.3010 Section 888.3010...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3010 Bone fixation cerclage. (a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as...

21 CFR 888.3015 - Bone heterograft.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Bone heterograft. 888.3015 Section 888.3015 Food... DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3015 Bone heterograft. (a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to...

21 CFR 888.3015 - Bone heterograft.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Bone heterograft. 888.3015 Section 888.3015 Food... DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3015 Bone heterograft. (a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to...

21 CFR 888.3015 - Bone heterograft.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone heterograft. 888.3015 Section 888.3015 Food... DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3015 Bone heterograft. (a) Identification. Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to...

21 CFR 888.3010 - Bone fixation cerclage.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Bone fixation cerclage. 888.3010 Section 888.3010...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3010 Bone fixation cerclage. (a) Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as...

21 CFR 874.3400 - Tinnitus masker.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tinnitus masker. 874.3400 Section 874.3400 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3400 Tinnitus masker. (a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to...

21 CFR 874.3400 - Tinnitus masker.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tinnitus masker. 874.3400 Section 874.3400 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3400 Tinnitus masker. (a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to...

21 CFR 874.3400 - Tinnitus masker.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Tinnitus masker. 874.3400 Section 874.3400 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3400 Tinnitus masker. (a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to...

21 CFR 874.3400 - Tinnitus masker.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tinnitus masker. 874.3400 Section 874.3400 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3400 Tinnitus masker. (a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to...

21 CFR 874.3400 - Tinnitus masker.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tinnitus masker. 874.3400 Section 874.3400 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3400 Tinnitus masker. (a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 872.3580 - Preformed gold denture tooth.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Preformed gold denture tooth. 872.3580 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3580 Preformed gold denture tooth. (a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75...

21 CFR 872.3580 - Preformed gold denture tooth.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Preformed gold denture tooth. 872.3580 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3580 Preformed gold denture tooth. (a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75...

21 CFR 872.3580 - Preformed gold denture tooth.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Preformed gold denture tooth. 872.3580 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3580 Preformed gold denture tooth. (a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75...

21 CFR 872.3580 - Preformed gold denture tooth.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Preformed gold denture tooth. 872.3580 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3580 Preformed gold denture tooth. (a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75...

21 CFR 872.3580 - Preformed gold denture tooth.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Preformed gold denture tooth. 872.3580 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3580 Preformed gold denture tooth. (a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental amalgam, mercury, and amalgam alloy. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3070 Dental amalgam, mercury, and amalgam alloy. (a) Identification. Dental amalgam is a device that consists of a combination of...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3640 - Endosseous dental implant.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental amalgam, mercury, and amalgam alloy. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3070 Dental amalgam, mercury, and amalgam alloy. (a) Identification. Dental amalgam is a device that consists of a combination of...

21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental amalgam, mercury, and amalgam alloy. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3070 Dental amalgam, mercury, and amalgam alloy. (a) Identification. Dental amalgam is a device that consists of a combination of...

21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental amalgam, mercury, and amalgam alloy. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3070 Dental amalgam, mercury, and amalgam alloy. (a) Identification. Dental amalgam is a device that consists of a combination of...

21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental amalgam, mercury, and amalgam alloy. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3070 Dental amalgam, mercury, and amalgam alloy. (a) Identification. Dental amalgam is a device that consists of a combination of...

21 CFR 872.3530 - Mechanical denture cleaner.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mechanical denture cleaner. 872.3530 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3530 Mechanical denture cleaner. (a) Identification. A mechanical denture cleaner is a device, usually AC-powered, that consists of a container for...

21 CFR 872.3600 - Partially fabricated denture kit.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Partially fabricated denture kit. 872.3600 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3600 Partially fabricated denture kit. (a) Identification. A partially fabricated denture kit is a device composed of connected preformed teeth that is...

21 CFR 872.3600 - Partially fabricated denture kit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Partially fabricated denture kit. 872.3600 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3600 Partially fabricated denture kit. (a) Identification. A partially fabricated denture kit is a device composed of connected preformed teeth that is...

21 CFR 872.3600 - Partially fabricated denture kit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Partially fabricated denture kit. 872.3600 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3600 Partially fabricated denture kit. (a) Identification. A partially fabricated denture kit is a device composed of connected preformed teeth that is...

21 CFR 872.3600 - Partially fabricated denture kit.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Partially fabricated denture kit. 872.3600 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3600 Partially fabricated denture kit. (a) Identification. A partially fabricated denture kit is a device composed of connected preformed teeth that is...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 888.3780 - Wrist joint polymer constrained prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wrist joint polymer constrained prosthesis. 888... SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3780 Wrist joint polymer constrained prosthesis. (a) Identification. A wrist joint polymer constrained prosthesis is a device made of...

21 CFR 888.3720 - Toe joint polymer constrained prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Toe joint polymer constrained prosthesis. 888.3720... (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3720 Toe joint polymer constrained prosthesis. (a) Identification. A toe joint polymer constrained prosthesis is a device made of silicone...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet. (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor. (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric mesh bag. (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a...

21 CFR 872.3590 - Preformed plastic denture tooth.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Preformed plastic denture tooth. 872.3590 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3590 Preformed plastic denture tooth. (a) Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl...

21 CFR 872.3750 - Bracket adhesive resin and tooth conditioner.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Bracket adhesive resin and tooth conditioner. 872... SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3750 Bracket adhesive resin and tooth conditioner. (a) Identification. A bracket adhesive resin and tooth conditioner is a device...

21 CFR 872.3830 - Endodontic paper point.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Endodontic paper point. 872.3830 Section 872.3830...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3830 Endodontic paper point. (a) Identification. An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry...

21 CFR 872.3830 - Endodontic paper point.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endodontic paper point. 872.3830 Section 872.3830...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3830 Endodontic paper point. (a) Identification. An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 872.3850 - Gutta percha.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Gutta percha. 872.3850 Section 872.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3850 Gutta percha. (a) Identification. Gutta percha is a device...

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 872.3590 - Preformed plastic denture tooth.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Preformed plastic denture tooth. 872.3590 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3590 Preformed plastic denture tooth. (a) Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 872.3590 - Preformed plastic denture tooth.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Preformed plastic denture tooth. 872.3590 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3590 Preformed plastic denture tooth. (a) Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl...

21 CFR 872.3590 - Preformed plastic denture tooth.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Preformed plastic denture tooth. 872.3590 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3590 Preformed plastic denture tooth. (a) Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl...

21 CFR 872.3590 - Preformed plastic denture tooth.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Preformed plastic denture tooth. 872.3590 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3590 Preformed plastic denture tooth. (a) Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Passive tendon prosthesis. 888.3025 Section 888...) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a) Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a...

Self-cleaning skin-like prosthetic polymer surfaces

DOEpatents

Simpson, John T [Clinton, TN; Ivanov, Ilia N [Knoxville, TN; Shibata, Jason [Manhattan Beach, CA

2012-03-27

An external covering and method of making an external covering for hiding the internal endoskeleton of a mechanical (e.g., prosthetic) device that exhibits skin-like qualities is provided. The external covering generally comprises an internal bulk layer in contact with the endoskeleton of the prosthetic device and an external skin layer disposed about the internal bulk layer. The external skin layer is comprised of a polymer composite with carbon nanotubes embedded therein. The outer surface of the skin layer has multiple cone-shaped projections that provide the external skin layer with superhydrophobicity. The carbon nanotubes are preferably vertically aligned between the inner surface and outer surface of the external skin layer in order to provide the skin layer with the ability to transmit heat. Superhydrophobic powders may optionally be used as part of the polymer composite or applied as a coating to the surface of the skin layer to enhance superhydrophobicity.

Method of making self-cleaning skin-like prosthetic polymer surfaces

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

Simpson, John T.; Ivanov, Ilia N.; Shibata, Jason

An external covering and method of making an external covering for hiding the internal endoskeleton of a mechanical (e.g., prosthetic) device that exhibits skin-like qualities is provided. The external covering generally comprises an internal bulk layer in contact with the endoskeleton of the prosthetic device and an external skin layer disposed about the internal bulk layer. The external skin layer is comprised of a polymer composite with carbon nanotubes embedded therein. The outer surface of the skin layer has multiple cone-shaped projections that provide the external skin layer with superhydrophobicity. The carbon nanotubes are preferably vertically aligned between the innermore » surface and outer surface of the external skin layer in order to provide the skin layer with the ability to transmit heat. Superhydrophobic powders may optionally be used as part of the polymer composite or applied as a coating to the surface of the skin layer to enhance superhydrophobicity.« less

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker programmers. 870.3700 Section 870.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers...

Optical 3D methods for measurement of prosthetic wear of total hip arthroplasty: principles, verification and results.

PubMed

Rossler, Tomas; Mandat, Dusan; Gallo, Jiri; Hrabovsky, Miroslav; Pochmon, Michal; Havranek, Vitezslav

2009-07-20

Total hip arthroplasty (THA) significantly improves the quality of life in majority of patients with severe osteoarthritis. However, long-term outcomes of THAs are compromised by aseptic loosening and periprosthetic osteolysis which needs revision surgery. Both of these are causally linked to a prosthetic wear deliberated from the prosthetic articulating surfaces. As a result, there is a need to measure the mode and magnitude of wear. The paper evaluates three optical methods proposed for construction of a device for the non-contact prosthetic wear measurement. Of them, the scanning profilometry achieved promising combination of accuracy and repeatability. Simultaneously, it is time efficient to enable the development of a sensor for wear measurement.

Representing high-dimensional data to intelligent prostheses and other wearable assistive robots: A first comparison of tile coding and selective Kanerva coding.

PubMed

Travnik, Jaden B; Pilarski, Patrick M

2017-07-01

Prosthetic devices have advanced in their capabilities and in the number and type of sensors included in their design. As the space of sensorimotor data available to a conventional or machine learning prosthetic control system increases in dimensionality and complexity, it becomes increasingly important that this data be represented in a useful and computationally efficient way. Well structured sensory data allows prosthetic control systems to make informed, appropriate control decisions. In this study, we explore the impact that increased sensorimotor information has on current machine learning prosthetic control approaches. Specifically, we examine the effect that high-dimensional sensory data has on the computation time and prediction performance of a true-online temporal-difference learning prediction method as embedded within a resource-limited upper-limb prosthesis control system. We present results comparing tile coding, the dominant linear representation for real-time prosthetic machine learning, with a newly proposed modification to Kanerva coding that we call selective Kanerva coding. In addition to showing promising results for selective Kanerva coding, our results confirm potential limitations to tile coding as the number of sensory input dimensions increases. To our knowledge, this study is the first to explicitly examine representations for realtime machine learning prosthetic devices in general terms. This work therefore provides an important step towards forming an efficient prosthesis-eye view of the world, wherein prompt and accurate representations of high-dimensional data may be provided to machine learning control systems within artificial limbs and other assistive rehabilitation technologies.

Development of a Prototype Over-Actuated Biomimetic Prosthetic Hand

PubMed Central

Williams, Matthew R.; Walter, Wayne

2015-01-01

The loss of a hand can greatly affect quality of life. A prosthetic device that can mimic normal hand function is very important to physical and mental recuperation after hand amputation, but the currently available prosthetics do not fully meet the needs of the amputee community. Most prosthetic hands are not dexterous enough to grasp a variety of shaped objects, and those that are tend to be heavy, leading to discomfort while wearing the device. In order to attempt to better simulate human hand function, a dexterous hand was developed that uses an over-actuated mechanism to form grasp shape using intrinsic joint mounted motors in addition to a finger tendon to produce large flexion force for a tight grip. This novel actuation method allows the hand to use small actuators for grip shape formation, and the tendon to produce high grip strength. The hand was capable of producing fingertip flexion force suitable for most activities of daily living. In addition, it was able to produce a range of grasp shapes with natural, independent finger motion, and appearance similar to that of a human hand. The hand also had a mass distribution more similar to a natural forearm and hand compared to contemporary prosthetics due to the more proximal location of the heavier components of the system. This paper describes the design of the hand and controller, as well as the test results. PMID:25790306

21 CFR 876.3750 - Testicular prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Testicular prosthesis. 876.3750 Section 876.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3750 Testicular prosthesis. (a...

21 CFR 872.3165 - Precision attachment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Precision attachment. 872.3165 Section 872.3165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3165 Precision attachment. (a) Identification. A...

21 CFR 872.3150 - Articulator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Articulator. 872.3150 Section 872.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3150 Articulator. (a) Identification. An articulator is a...

21 CFR 890.3920 - Wheelchair component.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wheelchair component. 890.3920 Section 890.3920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3920 Wheelchair...

21 CFR 890.3930 - Wheelchair elevator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wheelchair elevator. 890.3930 Section 890.3930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3930 Wheelchair...

21 CFR 890.3930 - Wheelchair elevator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wheelchair elevator. 890.3930 Section 890.3930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3930 Wheelchair...

21 CFR 890.3150 - Crutch.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Crutch. 890.3150 Section 890.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3150 Crutch. (a) Identification. A...

21 CFR 890.3910 - Wheelchair accessory.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wheelchair accessory. 890.3910 Section 890.3910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3910 Wheelchair...

21 CFR 890.3930 - Wheelchair elevator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wheelchair elevator. 890.3930 Section 890.3930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3930 Wheelchair...

21 CFR 890.3520 - Plinth.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Plinth. 890.3520 Section 890.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3520 Plinth. (a) Identification. A...

21 CFR 890.3910 - Wheelchair accessory.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wheelchair accessory. 890.3910 Section 890.3910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3910 Wheelchair...

21 CFR 890.3700 - Nonpowered communication system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonpowered communication system. 890.3700 Section 890.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3700...

21 CFR 890.3700 - Nonpowered communication system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nonpowered communication system. 890.3700 Section 890.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3700...

21 CFR 890.3700 - Nonpowered communication system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nonpowered communication system. 890.3700 Section 890.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3700...

21 CFR 890.3910 - Wheelchair accessory.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wheelchair accessory. 890.3910 Section 890.3910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3910 Wheelchair...

21 CFR 890.3920 - Wheelchair component.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wheelchair component. 890.3920 Section 890.3920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3920 Wheelchair...

21 CFR 890.3850 - Mechanical wheelchair.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mechanical wheelchair. 890.3850 Section 890.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3850 Mechanical...

21 CFR 890.3850 - Mechanical wheelchair.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mechanical wheelchair. 890.3850 Section 890.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3850 Mechanical...

21 CFR 890.3920 - Wheelchair component.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wheelchair component. 890.3920 Section 890.3920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3920 Wheelchair...

21 CFR 890.3520 - Plinth.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Plinth. 890.3520 Section 890.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3520 Plinth. (a) Identification. A...

21 CFR 890.3850 - Mechanical wheelchair.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mechanical wheelchair. 890.3850 Section 890.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3850 Mechanical...

21 CFR 890.3920 - Wheelchair component.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wheelchair component. 890.3920 Section 890.3920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3920 Wheelchair...

21 CFR 890.3150 - Crutch.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Crutch. 890.3150 Section 890.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3150 Crutch. (a) Identification. A...

21 CFR 890.3520 - Plinth.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Plinth. 890.3520 Section 890.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3520 Plinth. (a) Identification. A...

21 CFR 890.3150 - Crutch.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Crutch. 890.3150 Section 890.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3150 Crutch. (a) Identification. A...

21 CFR 890.3150 - Crutch.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Crutch. 890.3150 Section 890.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3150 Crutch. (a) Identification. A...

21 CFR 890.3910 - Wheelchair accessory.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wheelchair accessory. 890.3910 Section 890.3910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3910 Wheelchair...

21 CFR 890.3520 - Plinth.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Plinth. 890.3520 Section 890.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3520 Plinth. (a) Identification. A...

21 CFR 890.3850 - Mechanical wheelchair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mechanical wheelchair. 890.3850 Section 890.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3850 Mechanical...

21 CFR 890.3920 - Wheelchair component.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wheelchair component. 890.3920 Section 890.3920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3920 Wheelchair...

21 CFR 890.3700 - Nonpowered communication system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nonpowered communication system. 890.3700 Section 890.3700 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3700...

21 CFR 890.3150 - Crutch.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Crutch. 890.3150 Section 890.3150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3150 Crutch. (a) Identification. A...

21 CFR 890.3850 - Mechanical wheelchair.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical wheelchair. 890.3850 Section 890.3850 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3850 Mechanical...

21 CFR 890.3910 - Wheelchair accessory.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wheelchair accessory. 890.3910 Section 890.3910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3910 Wheelchair...

21 CFR 890.3520 - Plinth.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Plinth. 890.3520 Section 890.3520 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3520 Plinth. (a) Identification. A...

21 CFR 870.3450 - Vascular graft prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular graft prosthesis. 870.3450 Section 870.3450 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3450 Vascular graft...

21 CFR 870.3670 - Pacemaker charger.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker charger. 870.3670 Section 870.3670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3670 Pacemaker charger. (a...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 878.3610 - Esophageal prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Esophageal prosthesis. 878.3610 Section 878.3610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3610 Esophageal prosthesis...

21 CFR 872.3770 - Temporary crown and bridge resin.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Temporary crown and bridge resin. 872.3770 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3770 Temporary crown and bridge resin. (a) Identification. A temporary crown and bridge resin is a device composed of a material, such as...

21 CFR 872.3060 - Noble metal alloy.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Noble metal alloy. 872.3060 Section 872.3060 Food... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3060 Noble metal alloy. (a) Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that...

21 CFR 872.3060 - Noble metal alloy.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Noble metal alloy. 872.3060 Section 872.3060 Food... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3060 Noble metal alloy. (a) Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that...

21 CFR 872.3080 - Mercury and alloy dispenser.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mercury and alloy dispenser. 872.3080 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3080 Mercury and alloy dispenser. (a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and...

21 CFR 872.3080 - Mercury and alloy dispenser.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mercury and alloy dispenser. 872.3080 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3080 Mercury and alloy dispenser. (a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and...

21 CFR 872.3080 - Mercury and alloy dispenser.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mercury and alloy dispenser. 872.3080 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3080 Mercury and alloy dispenser. (a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and...

21 CFR 872.3080 - Mercury and alloy dispenser.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mercury and alloy dispenser. 872.3080 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3080 Mercury and alloy dispenser. (a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and...

21 CFR 874.3330 - Master hearing aid.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Master hearing aid. 874.3330 Section 874.3330 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3330 Master hearing aid. (a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric...

21 CFR 874.3330 - Master hearing aid.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Master hearing aid. 874.3330 Section 874.3330 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3330 Master hearing aid. (a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric...

21 CFR 874.3330 - Master hearing aid.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Master hearing aid. 874.3330 Section 874.3330 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3330 Master hearing aid. (a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric...

21 CFR 874.3330 - Master hearing aid.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Master hearing aid. 874.3330 Section 874.3330 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3330 Master hearing aid. (a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric...

21 CFR 874.3330 - Master hearing aid.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Master hearing aid. 874.3330 Section 874.3330 Food... DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3330 Master hearing aid. (a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric...

21 CFR 872.3250 - Calcium hydroxide cavity liner.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Calcium hydroxide cavity liner. 872.3250 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3250 Calcium hydroxide cavity liner. (a) Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a...

21 CFR 872.3250 - Calcium hydroxide cavity liner.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Calcium hydroxide cavity liner. 872.3250 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3250 Calcium hydroxide cavity liner. (a) Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a...

21 CFR 872.3110 - Dental amalgam capsule.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental amalgam capsule. 872.3110 Section 872.3110...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3110 Dental amalgam capsule. (a) Identification. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury...

21 CFR 872.3110 - Dental amalgam capsule.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental amalgam capsule. 872.3110 Section 872.3110...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3110 Dental amalgam capsule. (a) Identification. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury...

21 CFR 872.3110 - Dental amalgam capsule.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental amalgam capsule. 872.3110 Section 872.3110...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3110 Dental amalgam capsule. (a) Identification. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury...

21 CFR 872.3110 - Dental amalgam capsule.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental amalgam capsule. 872.3110 Section 872.3110...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3110 Dental amalgam capsule. (a) Identification. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury...

21 CFR 872.3110 - Dental amalgam capsule.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental amalgam capsule. 872.3110 Section 872.3110...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3110 Dental amalgam capsule. (a) Identification. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury...

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Intra-aortic balloon and control system 870.3535... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic balloon and control system (a) Identification. A intra-aortic balloon and control system is a device that...

21 CFR 870.3535 - Intra-aortic balloon and control system

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intra-aortic balloon and control system 870.3535... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3535 Intra-aortic balloon and control system (a) Identification. A intra-aortic balloon and control system is a device that...

21 CFR 872.3250 - Calcium hydroxide cavity liner.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Calcium hydroxide cavity liner. 872.3250 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3250 Calcium hydroxide cavity liner. (a) Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a...

21 CFR 872.3250 - Calcium hydroxide cavity liner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Calcium hydroxide cavity liner. 872.3250 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3250 Calcium hydroxide cavity liner. (a) Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a...

21 CFR 872.3250 - Calcium hydroxide cavity liner.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Calcium hydroxide cavity liner. 872.3250 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3250 Calcium hydroxide cavity liner. (a) Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a...

21 CFR 872.3350 - Gold or stainless steel cusp.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Gold or stainless steel cusp. 872.3350 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3350 Gold or stainless steel cusp. (a) Identification. A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys...

21 CFR 872.3350 - Gold or stainless steel cusp.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Gold or stainless steel cusp. 872.3350 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3350 Gold or stainless steel cusp. (a) Identification. A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys...

21 CFR 872.3350 - Gold or stainless steel cusp.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Gold or stainless steel cusp. 872.3350 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3350 Gold or stainless steel cusp. (a) Identification. A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys...

21 CFR 872.3350 - Gold or stainless steel cusp.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Gold or stainless steel cusp. 872.3350 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3350 Gold or stainless steel cusp. (a) Identification. A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys...

21 CFR 872.3350 - Gold or stainless steel cusp.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Gold or stainless steel cusp. 872.3350 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3350 Gold or stainless steel cusp. (a) Identification. A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys...

21 CFR 872.3770 - Temporary crown and bridge resin.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Temporary crown and bridge resin. 872.3770 Section... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3770 Temporary crown and bridge resin. (a) Identification. A temporary crown and bridge resin is a device composed of a material, such as...

Nuclear Medicine in Diagnosis of Prosthetic Valve Endocarditis: An Update

PubMed Central

Musso, Maria; Petrosillo, Nicola

2015-01-01

Over the past decades cardiovascular disease management has been substantially improved by the increasing introduction of medical devices as prosthetic valves. The yearly rate of infective endocarditis (IE) in patient with a prosthetic valve is approximately 3 cases per 1,000 patients. The fatality rate of prosthetic valve endocarditis (PVE) remains stable over the years, in part due to the aging of the population. The diagnostic value of echocardiography in diagnosis is operator-dependent and its sensitivity can decrease in presence of intracardiac devices and valvular prosthesis. The modified Duke criteria are considered the gold standard for diagnosing IE; their sensibility is 80%, but in clinical practice their diagnostic accuracy in PVE is lower, resulting inconclusively in nearly 30% of cases. In the last years, these new imaging modalities have gained an increasing attention because they make it possible to diagnose an IE earlier than the structural alterations occurring. Several studies have been conducted in order to assess the diagnostic accuracy of various nuclear medicine techniques in diagnosis of PVE. We performed a review of the literature to assess the available evidence on the role of nuclear medicine techniques in the diagnosis of PVE. PMID:25695043

Prosthetic rehabilitation of oral submucous fibrosis patients: A systematic review of published case reports and case series

PubMed Central

Patil, Shankargouda; Sarode, Gargi S.; Bhandi, Shilpa; Awan, Kamran Habib; Ferrari, Marco

2017-01-01

Background Oral submucous fibrosis (OSF) is an insidious chronic condition characterized by restricted mouth opening. Prosthetic rehabilitation is challenging for OSF patients as obtaining a good impression requires adequate mouth opening. The aim of the present review is to systematically present the data from case reports published in the English-language literature. Method A comprehensive search of the literature databases (PubMed, Medline, SCOPUS, Web of Science and Google Scholar) along with the references of published articles on prosthetic rehabilitation in OSF patients published to date was conducted. Keywords included a combination of ‘Oral submucous fibrosis’, ‘prosthesis’, ‘dentures’ and/or ‘restricted mouth opening’. Citations from selected references and bibliographic linkages taken from similar cases were included in this review. The inclusion criteria selected for case reports on prosthetic rehabilitation in OSF patients, and cases of restricted mouth opening due to causes other than OSF were excluded from the study. Results A total of 21 cases were identified and analysed from 17 papers published in the English-language literature. Of these, 9 cases employed the sectional denture technique, 4 cases emphasized the need-based treatment approach in which conventional methods were modified, and 4 cases used mouth exercising devices. Finally, 1 case each involved, flexible denture, oral screen prosthesis, oral stents, surgery in conjunction with dentures. Conclusion Prosthetic rehabilitation in OSF patients is a multifaceted approach and should be patient specific, although sectional dentures have achieved the best results. PMID:28877246

Prosthetic rehabilitation of oral submucous fibrosis patients: A systematic review of published case reports and case series.

PubMed

Patil, Shankargouda; Sarode, Sachin Chakradhar; Sarode, Gargi S; Bhandi, Shilpa; Awan, Kamran Habib; Ferrari, Marco

2017-01-01

Oral submucous fibrosis (OSF) is an insidious chronic condition characterized by restricted mouth opening. Prosthetic rehabilitation is challenging for OSF patients as obtaining a good impression requires adequate mouth opening. The aim of the present review is to systematically present the data from case reports published in the English-language literature. A comprehensive search of the literature databases (PubMed, Medline, SCOPUS, Web of Science and Google Scholar) along with the references of published articles on prosthetic rehabilitation in OSF patients published to date was conducted. Keywords included a combination of 'Oral submucous fibrosis', 'prosthesis', 'dentures' and/or 'restricted mouth opening'. Citations from selected references and bibliographic linkages taken from similar cases were included in this review. The inclusion criteria selected for case reports on prosthetic rehabilitation in OSF patients, and cases of restricted mouth opening due to causes other than OSF were excluded from the study. A total of 21 cases were identified and analysed from 17 papers published in the English-language literature. Of these, 9 cases employed the sectional denture technique, 4 cases emphasized the need-based treatment approach in which conventional methods were modified, and 4 cases used mouth exercising devices. Finally, 1 case each involved, flexible denture, oral screen prosthesis, oral stents, surgery in conjunction with dentures. Prosthetic rehabilitation in OSF patients is a multifaceted approach and should be patient specific, although sectional dentures have achieved the best results.

21 CFR 876.3630 - Penile rigidity implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Penile rigidity implant. 876.3630 Section 876.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Prosthetic Devices § 876.3630 Penile rigidity implant. (a...

21 CFR 872.3930 - Bone grafting material.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Bone grafting material. 872.3930 Section 872.3930...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3930 Bone grafting material. (a) Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and...

21 CFR 872.3930 - Bone grafting material.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Bone grafting material. 872.3930 Section 872.3930...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3930 Bone grafting material. (a) Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and...

21 CFR 872.3930 - Bone grafting material.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Bone grafting material. 872.3930 Section 872.3930...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3930 Bone grafting material. (a) Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and...

21 CFR 872.3930 - Bone grafting material.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Bone grafting material. 872.3930 Section 872.3930...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3930 Bone grafting material. (a) Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and...

21 CFR 872.3930 - Bone grafting material.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Bone grafting material. 872.3930 Section 872.3930...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3930 Bone grafting material. (a) Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and...

21 CFR 870.3250 - Vascular clip.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Vascular clip. 870.3250 Section 870.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3250 Vascular clip. (a) Identification. A vascular...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3020 - Intramedullary fixation rod.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Intramedullary fixation rod. 888.3020 Section 888.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3020 Intramedullary fixation rod. (a...

21 CFR 888.3050 - Spinal interlaminal fixation orthosis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Spinal interlaminal fixation orthosis. 888.3050 Section 888.3050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3050 Spinal interlaminal fixation...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3020 - Intramedullary fixation rod.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intramedullary fixation rod. 888.3020 Section 888.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3020 Intramedullary fixation rod. (a...

21 CFR 888.3025 - Passive tendon prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Passive tendon prosthesis. 888.3025 Section 888.3025 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3025 Passive tendon prosthesis. (a...

21 CFR 888.3020 - Intramedullary fixation rod.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Intramedullary fixation rod. 888.3020 Section 888.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3020 Intramedullary fixation rod. (a...

21 CFR 888.3020 - Intramedullary fixation rod.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intramedullary fixation rod. 888.3020 Section 888.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3020 Intramedullary fixation rod. (a...

21 CFR 888.3050 - Spinal interlaminal fixation orthosis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Spinal interlaminal fixation orthosis. 888.3050 Section 888.3050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3050 Spinal interlaminal fixation...

21 CFR 888.3020 - Intramedullary fixation rod.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Intramedullary fixation rod. 888.3020 Section 888.3020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3020 Intramedullary fixation rod. (a...

21 CFR 888.3050 - Spinal interlaminal fixation orthosis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Spinal interlaminal fixation orthosis. 888.3050 Section 888.3050 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES Prosthetic Devices § 888.3050 Spinal interlaminal fixation...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 870.3710 - Pacemaker repair or replacement material.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker repair or replacement material. 870.3710... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3710 Pacemaker repair or replacement material. (a) Identification. A pacemaker repair or replacement material is an...

21 CFR 890.3490 - Truncal orthosis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Truncal orthosis. 890.3490 Section 890.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3490 Truncal orthosis. (a...

21 CFR 890.3475 - Limb orthosis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limb orthosis. 890.3475 Section 890.3475 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3475 Limb orthosis. (a) Identification...

21 CFR 890.3410 - External limb orthotic component.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false External limb orthotic component. 890.3410 Section 890.3410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3410...

21 CFR 890.3900 - Standup wheelchair.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Standup wheelchair. 890.3900 Section 890.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3900 Standup wheelchair. (a...

21 CFR 890.3880 - Special grade wheelchair.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Special grade wheelchair. 890.3880 Section 890.3880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3880 Special grade...

21 CFR 890.3490 - Truncal orthosis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Truncal orthosis. 890.3490 Section 890.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3490 Truncal orthosis. (a...

21 CFR 890.3475 - Limb orthosis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limb orthosis. 890.3475 Section 890.3475 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3475 Limb orthosis. (a) Identification...

21 CFR 890.3825 - Mechanical walker.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mechanical walker. 890.3825 Section 890.3825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3825 Mechanical walker. (a...

21 CFR 890.3860 - Powered wheelchair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered wheelchair. 890.3860 Section 890.3860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3860 Powered wheelchair. (a...

21 CFR 890.3075 - Cane.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cane. 890.3075 Section 890.3075 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3075 Cane. (a) Identification. A cane...

21 CFR 890.3900 - Standup wheelchair.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Standup wheelchair. 890.3900 Section 890.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3900 Standup wheelchair. (a...

21 CFR 890.3690 - Powered wheeled stretcher.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered wheeled stretcher. 890.3690 Section 890.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3690 Powered wheeled...

21 CFR 890.3900 - Standup wheelchair.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Standup wheelchair. 890.3900 Section 890.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3900 Standup wheelchair. (a...

21 CFR 890.3880 - Special grade wheelchair.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Special grade wheelchair. 890.3880 Section 890.3880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3880 Special grade...

21 CFR 890.3760 - Powered table.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered table. 890.3760 Section 890.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3760 Powered table. (a) Identification...

21 CFR 890.3825 - Mechanical walker.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mechanical walker. 890.3825 Section 890.3825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3825 Mechanical walker. (a...

21 CFR 890.3175 - Flotation cushion.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Flotation cushion. 890.3175 Section 890.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3175 Flotation cushion. (a...

21 CFR 890.3690 - Powered wheeled stretcher.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered wheeled stretcher. 890.3690 Section 890.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3690 Powered wheeled...

21 CFR 890.3475 - Limb orthosis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limb orthosis. 890.3475 Section 890.3475 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3475 Limb orthosis. (a) Identification...

21 CFR 890.3760 - Powered table.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered table. 890.3760 Section 890.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3760 Powered table. (a) Identification...

21 CFR 890.3750 - Mechanical table.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mechanical table. 890.3750 Section 890.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3750 Mechanical table. (a...

21 CFR 890.3410 - External limb orthotic component.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false External limb orthotic component. 890.3410 Section 890.3410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3410...

21 CFR 890.3880 - Special grade wheelchair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Special grade wheelchair. 890.3880 Section 890.3880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3880 Special grade...

21 CFR 890.3940 - Wheelchair platform scale.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Wheelchair platform scale. 890.3940 Section 890.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3940 Wheelchair...

21 CFR 890.3410 - External limb orthotic component.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false External limb orthotic component. 890.3410 Section 890.3410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3410...

21 CFR 890.3860 - Powered wheelchair.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered wheelchair. 890.3860 Section 890.3860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3860 Powered wheelchair. (a...

21 CFR 890.3890 - Stair-climbing wheelchair.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Stair-climbing wheelchair. 890.3890 Section 890.3890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3890 Stair-climbing...

21 CFR 890.3940 - Wheelchair platform scale.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Wheelchair platform scale. 890.3940 Section 890.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3940 Wheelchair...

21 CFR 890.3750 - Mechanical table.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mechanical table. 890.3750 Section 890.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3750 Mechanical table. (a...

21 CFR 890.3940 - Wheelchair platform scale.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Wheelchair platform scale. 890.3940 Section 890.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3940 Wheelchair...

21 CFR 890.3410 - External limb orthotic component.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false External limb orthotic component. 890.3410 Section 890.3410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3410...

21 CFR 890.3900 - Standup wheelchair.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Standup wheelchair. 890.3900 Section 890.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3900 Standup wheelchair. (a...

21 CFR 890.3490 - Truncal orthosis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Truncal orthosis. 890.3490 Section 890.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3490 Truncal orthosis. (a...

21 CFR 890.3410 - External limb orthotic component.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false External limb orthotic component. 890.3410 Section 890.3410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3410...

21 CFR 890.3690 - Powered wheeled stretcher.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered wheeled stretcher. 890.3690 Section 890.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3690 Powered wheeled...

21 CFR 890.3760 - Powered table.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered table. 890.3760 Section 890.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3760 Powered table. (a) Identification...

21 CFR 890.3110 - Electric positioning chair.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Electric positioning chair. 890.3110 Section 890.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3110 Electric...

21 CFR 890.3175 - Flotation cushion.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Flotation cushion. 890.3175 Section 890.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3175 Flotation cushion. (a...

21 CFR 890.3110 - Electric positioning chair.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electric positioning chair. 890.3110 Section 890.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3110 Electric...

21 CFR 890.3100 - Mechanical chair.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mechanical chair. 890.3100 Section 890.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3100 Mechanical chair. (a...

21 CFR 890.3690 - Powered wheeled stretcher.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered wheeled stretcher. 890.3690 Section 890.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3690 Powered wheeled...

21 CFR 890.3075 - Cane.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cane. 890.3075 Section 890.3075 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3075 Cane. (a) Identification. A cane...

21 CFR 890.3800 - Motorized three-wheeled vehicle.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Motorized three-wheeled vehicle. 890.3800 Section 890.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3800...

21 CFR 890.3890 - Stair-climbing wheelchair.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Stair-climbing wheelchair. 890.3890 Section 890.3890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3890 Stair-climbing...

21 CFR 890.3750 - Mechanical table.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mechanical table. 890.3750 Section 890.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3750 Mechanical table. (a...

21 CFR 890.3860 - Powered wheelchair.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered wheelchair. 890.3860 Section 890.3860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3860 Powered wheelchair. (a...

21 CFR 890.3750 - Mechanical table.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mechanical table. 890.3750 Section 890.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3750 Mechanical table. (a...

21 CFR 890.3100 - Mechanical chair.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mechanical chair. 890.3100 Section 890.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3100 Mechanical chair. (a...

21 CFR 890.3710 - Powered communication system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered communication system. 890.3710 Section 890.3710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3710 Powered...

21 CFR 890.3710 - Powered communication system.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered communication system. 890.3710 Section 890.3710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3710 Powered...

21 CFR 890.3110 - Electric positioning chair.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electric positioning chair. 890.3110 Section 890.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3110 Electric...

21 CFR 890.3475 - Limb orthosis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limb orthosis. 890.3475 Section 890.3475 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3475 Limb orthosis. (a) Identification...

21 CFR 890.3100 - Mechanical chair.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical chair. 890.3100 Section 890.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3100 Mechanical chair. (a...

21 CFR 890.3110 - Electric positioning chair.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Electric positioning chair. 890.3110 Section 890.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3110 Electric...

21 CFR 890.3825 - Mechanical walker.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical walker. 890.3825 Section 890.3825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3825 Mechanical walker. (a...

21 CFR 890.3800 - Motorized three-wheeled vehicle.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Motorized three-wheeled vehicle. 890.3800 Section 890.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3800...

21 CFR 890.3890 - Stair-climbing wheelchair.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Stair-climbing wheelchair. 890.3890 Section 890.3890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3890 Stair-climbing...

21 CFR 890.3175 - Flotation cushion.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Flotation cushion. 890.3175 Section 890.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3175 Flotation cushion. (a...

21 CFR 890.3825 - Mechanical walker.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Mechanical walker. 890.3825 Section 890.3825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3825 Mechanical walker. (a...

21 CFR 890.3860 - Powered wheelchair.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered wheelchair. 890.3860 Section 890.3860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3860 Powered wheelchair. (a...

21 CFR 890.3175 - Flotation cushion.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Flotation cushion. 890.3175 Section 890.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3175 Flotation cushion. (a...

21 CFR 890.3075 - Cane.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cane. 890.3075 Section 890.3075 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3075 Cane. (a) Identification. A cane...

21 CFR 890.3475 - Limb orthosis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Limb orthosis. 890.3475 Section 890.3475 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3475 Limb orthosis. (a) Identification...

21 CFR 890.3890 - Stair-climbing wheelchair.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Stair-climbing wheelchair. 890.3890 Section 890.3890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3890 Stair-climbing...

21 CFR 890.3710 - Powered communication system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered communication system. 890.3710 Section 890.3710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3710 Powered...

21 CFR 890.3490 - Truncal orthosis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Truncal orthosis. 890.3490 Section 890.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3490 Truncal orthosis. (a...

21 CFR 890.3690 - Powered wheeled stretcher.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered wheeled stretcher. 890.3690 Section 890.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3690 Powered wheeled...

21 CFR 890.3490 - Truncal orthosis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Truncal orthosis. 890.3490 Section 890.3490 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3490 Truncal orthosis. (a...

21 CFR 890.3760 - Powered table.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered table. 890.3760 Section 890.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3760 Powered table. (a) Identification...

21 CFR 890.3890 - Stair-climbing wheelchair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Stair-climbing wheelchair. 890.3890 Section 890.3890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3890 Stair-climbing...

21 CFR 890.3075 - Cane.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cane. 890.3075 Section 890.3075 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3075 Cane. (a) Identification. A cane...

21 CFR 890.3100 - Mechanical chair.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mechanical chair. 890.3100 Section 890.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3100 Mechanical chair. (a...

21 CFR 890.3800 - Motorized three-wheeled vehicle.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Motorized three-wheeled vehicle. 890.3800 Section 890.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3800...

21 CFR 890.3860 - Powered wheelchair.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered wheelchair. 890.3860 Section 890.3860 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3860 Powered wheelchair. (a...

21 CFR 890.3880 - Special grade wheelchair.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Special grade wheelchair. 890.3880 Section 890.3880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3880 Special grade...

21 CFR 890.3110 - Electric positioning chair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Electric positioning chair. 890.3110 Section 890.3110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3110 Electric...

21 CFR 890.3800 - Motorized three-wheeled vehicle.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Motorized three-wheeled vehicle. 890.3800 Section 890.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3800...

21 CFR 890.3710 - Powered communication system.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered communication system. 890.3710 Section 890.3710 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3710 Powered...

21 CFR 890.3900 - Standup wheelchair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Standup wheelchair. 890.3900 Section 890.3900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3900 Standup wheelchair. (a...

21 CFR 890.3760 - Powered table.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered table. 890.3760 Section 890.3760 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3760 Powered table. (a) Identification...

21 CFR 890.3825 - Mechanical walker.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mechanical walker. 890.3825 Section 890.3825 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3825 Mechanical walker. (a...

21 CFR 890.3750 - Mechanical table.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Mechanical table. 890.3750 Section 890.3750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3750 Mechanical table. (a...

21 CFR 890.3800 - Motorized three-wheeled vehicle.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Motorized three-wheeled vehicle. 890.3800 Section 890.3800 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3800...

21 CFR 890.3175 - Flotation cushion.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Flotation cushion. 890.3175 Section 890.3175 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3175 Flotation cushion. (a...

21 CFR 890.3075 - Cane.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cane. 890.3075 Section 890.3075 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3075 Cane. (a) Identification. A cane...

21 CFR 890.3100 - Mechanical chair.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mechanical chair. 890.3100 Section 890.3100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3100 Mechanical chair. (a...

21 CFR 890.3880 - Special grade wheelchair.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Special grade wheelchair. 890.3880 Section 890.3880 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3880 Special grade...

21 CFR 890.3940 - Wheelchair platform scale.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Wheelchair platform scale. 890.3940 Section 890.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3940 Wheelchair...

21 CFR 890.3940 - Wheelchair platform scale.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Wheelchair platform scale. 890.3940 Section 890.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES Physical Medicine Prosthetic Devices § 890.3940 Wheelchair...

21 CFR 870.3640 - Indirect pacemaker generator function analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Indirect pacemaker generator function analyzer. 870.3640 Section 870.3640 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3640...

21 CFR 870.3620 - Pacemaker lead adaptor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker lead adaptor. 870.3620 Section 870.3620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3620 Pacemaker lead adaptor...

21 CFR 870.3650 - Pacemaker polymeric mesh bag.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker polymeric mesh bag. 870.3650 Section 870.3650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3650 Pacemaker polymeric...

21 CFR 870.3630 - Pacemaker generator function analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker generator function analyzer. 870.3630 Section 870.3630 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3630 Pacemaker...

21 CFR 870.3250 - Vascular clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Vascular clip. 870.3250 Section 870.3250 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3250 Vascular clip. (a) Identification. A vascular...

21 CFR 870.3690 - Pacemaker test magnet.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker test magnet. 870.3690 Section 870.3690 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3690 Pacemaker test magnet...

21 CFR 872.3890 - Endodontic stabilizing splint.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endodontic stabilizing splint. 872.3890 Section 872.3890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3890 Endodontic stabilizing splint. (a...

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Mandibular condyle prosthesis. 872.3960 Section 872.3960 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a...

21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Interarticular disc prosthesis (interpositional implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3970 Interarticular...

21 CFR 872.3830 - Endodontic paper point.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endodontic paper point. 872.3830 Section 872.3830 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3830 Endodontic paper point. (a) Identification...

21 CFR 872.3840 - Endodontic silver point.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Endodontic silver point. 872.3840 Section 872.3840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3840 Endodontic silver point. (a) Identification...

21 CFR 872.3940 - Total temporomandibular joint prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Total temporomandibular joint prosthesis. 872.3940 Section 872.3940 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3940 Total temporomandibular joint...

21 CFR 872.3950 - Glenoid fossa prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Glenoid fossa prosthesis. 872.3950 Section 872.3950 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3950 Glenoid fossa prosthesis. (a) Identification...

21 CFR 878.3910 - Noninflatable extremity splint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Noninflatable extremity splint. 878.3910 Section 878.3910 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3910 Noninflatable...