USA/1213
WTO/TBT
US Vereinigte Staaten von Amerika
2017-01-01
2016-11-07

Upper extremity prosthesis. Medical equipment (ICS: 11.040)

Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components (3 pages, in English)

The Food and Drug Administration (FDA) is classifying the UpperExtremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder withGreater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls thatwill apply to the device are identified in this order and will be part of the codified languagefor the upper extremity prosthesis including a simultaneously powered elbow and/orshoulder with greater than two simultaneous powered degrees of freedom and controlledby non-implanted electrical components' classification. The Agency is classifying the deviceinto class II (special controls) in order to provide a reasonable assurance of safety andeffectiveness of the device.

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