FDA product code ITC: Stirrup, External Brace Component
ITC is the FDA product code for stirrup, external brace component. It is a Class I device, regulated under 21 CFR 890.3410 and reviewed by the Physical Medicine panel. Devices under ITC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stirrup, External Brace Component |
| Device class | Class I |
| Regulation | 21 CFR 890.3410 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for ITC devices
openFDA lists no recalls for product code ITC.
Frequently asked questions
What is FDA product code ITC?
ITC is the FDA product code for stirrup, external brace component. It is a Class I device, regulated under 21 CFR 890.3410 and reviewed by the Physical Medicine panel.
What device class is ITC?
Class I, regulation 21 CFR 890.3410. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code ITC
- Run a recall and safety report across every ITC manufacturer
- Watch product code ITC 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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