# 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
> **Food and Drug Administration** · Final order. · Published 2016-10-18 · Effective 2016-10-18 · 81 FR 71610
## Document
- **Document number:** 2016-25001
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 71610
- **CFR reference:** 21 CFR 890
- **Publication date:** 2016-10-18
- **Effective date:** 2016-10-18
- **HHS docket:** Docket No. FDA-2016-N-2829
## Abstract

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

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/10/18/2016-25001/medical-devices-physical-medicine-devices-classification-of-the-upper-extremity-prosthesis-including)
---
*AI Analytics · CC0 1.0*