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