FDA product code IQZ: Hand, External Limb Component, Powered
IQZ is the FDA product code for hand, 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 IQZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for IQZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Hand, 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 IQZ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-08-22.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code IQZ?
IQZ is the FDA product code for hand, 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 IQZ?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
Have IQZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-08-22.
Next steps
- Run an FDA pathway report with predicate devices for product code IQZ
- Run a recall and safety report across every IQZ manufacturer
- Watch product code IQZ 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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