FDA product code KFT: Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical
KFT is the FDA product code for assembly, shoulder/elbow/forearm/wrist/hand, mechanical. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. Devices under KFT 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, Mechanical |
| Device class | Class I |
| Regulation | 21 CFR 890.3420 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for KFT devices
openFDA lists no recalls for product code KFT.
Frequently asked questions
What is FDA product code KFT?
KFT is the FDA product code for assembly, shoulder/elbow/forearm/wrist/hand, mechanical. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is KFT?
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 KFT
- Run a recall and safety report across every KFT manufacturer
- Watch product code KFT 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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