FDA product code IQW: Hook, External Limb Component, Powered
IQW is the FDA product code for hook, external limb component, powered. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. Devices under IQW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Hook, External Limb Component, 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 IQW devices
openFDA lists no recalls for product code IQW.
Frequently asked questions
What is FDA product code IQW?
IQW is the FDA product code for hook, external limb component, powered. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is IQW?
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 IQW
- Run a recall and safety report across every IQW manufacturer
- Watch product code IQW 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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