FDA product code PAE: Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
PAE is the FDA product code for upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography. It is a Class II device, regulated under 21 CFR 890.3450 and reviewed by the Physical Medicine panel. Devices under PAE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality.
Classification
| Field | Value |
|---|---|
| Device name | Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography |
| Device class | Class II |
| Regulation | 21 CFR 890.3450 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
Recalls for PAE devices
openFDA lists no recalls for product code PAE.
Frequently asked questions
What is FDA product code PAE?
PAE is the FDA product code for upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography. It is a Class II device, regulated under 21 CFR 890.3450 and reviewed by the Physical Medicine panel.
What device class is PAE?
Class II, regulation 21 CFR 890.3450. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PAE
- Run a recall and safety report across every PAE manufacturer
- Watch product code PAE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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