FDA product code QKC: Interactive Rehabilitation Exercise Device, Prescription Use
QKC is the FDA product code for interactive rehabilitation exercise device, prescription use. It is a Class II device, regulated under 21 CFR 890.5360 and reviewed by the Physical Medicine panel. Devices under QKC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform.
Classification
| Field | Value |
|---|---|
| Device name | Interactive Rehabilitation Exercise Device, Prescription Use |
| Device class | Class II |
| Regulation | 21 CFR 890.5360 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for QKC devices
openFDA lists no recalls for product code QKC.
Frequently asked questions
What is FDA product code QKC?
QKC is the FDA product code for interactive rehabilitation exercise device, prescription use. It is a Class II device, regulated under 21 CFR 890.5360 and reviewed by the Physical Medicine panel.
What device class is QKC?
Class II, regulation 21 CFR 890.5360. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QKC
- Run a recall and safety report across every QKC manufacturer
- Watch product code QKC 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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