FDA product code KFW: Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered
KFW is the FDA product code for assembly, shoulder/elbow/forearm/wrist/hand, powered. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. Devices under KFW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered |
| Device class | Class I |
| Regulation | 21 CFR 890.3420 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KFW devices
openFDA lists no recalls for product code KFW.
Frequently asked questions
What is FDA product code KFW?
KFW is the FDA product code for assembly, shoulder/elbow/forearm/wrist/hand, powered. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is KFW?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KFW
- Run a recall and safety report across every KFW manufacturer
- Watch product code KFW 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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