FDA product code IKP: Chronaximeter
IKP is the FDA product code for chronaximeter. It is a Class II device, regulated under 21 CFR 890.1225 and reviewed by the Physical Medicine panel. Devices under IKP reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chronaximeter |
| Device class | Class II |
| Regulation | 21 CFR 890.1225 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for IKP devices
openFDA lists no recalls for product code IKP.
Frequently asked questions
What is FDA product code IKP?
IKP is the FDA product code for chronaximeter. It is a Class II device, regulated under 21 CFR 890.1225 and reviewed by the Physical Medicine panel.
What device class is IKP?
Class II, regulation 21 CFR 890.1225. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code IKP
- Run a recall and safety report across every IKP manufacturer
- Watch product code IKP 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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