FDA product code IRD: Joint, Elbow, External Limb Component, Mechanical
IRD is the FDA product code for joint, elbow, 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 IRD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Joint, Elbow, 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 IRD devices
openFDA lists no recalls for product code IRD.
Frequently asked questions
What is FDA product code IRD?
IRD is the FDA product code for joint, elbow, 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 IRD?
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 IRD
- Run a recall and safety report across every IRD manufacturer
- Watch product code IRD 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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