FDA product code PKS: Exerciser, Non-Measuring For Stroke Rehabilitation
PKS is the FDA product code for exerciser, non-measuring for stroke rehabilitation. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel. Devices under PKS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.
Classification
| Field | Value |
|---|---|
| Device name | Exerciser, Non-Measuring For Stroke Rehabilitation |
| Device class | Class I |
| Regulation | 21 CFR 890.5370 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for PKS devices
openFDA lists no recalls for product code PKS.
Frequently asked questions
What is FDA product code PKS?
PKS is the FDA product code for exerciser, non-measuring for stroke rehabilitation. It is a Class I device, regulated under 21 CFR 890.5370 and reviewed by the Physical Medicine panel.
What device class is PKS?
Class I, regulation 21 CFR 890.5370. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PKS
- Run a recall and safety report across every PKS manufacturer
- Watch product code PKS 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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