FDA product code IML: Armrest, Wheelchair
IML is the FDA product code for armrest, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel. Devices under IML reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Armrest, Wheelchair |
| Device class | Class I |
| Regulation | 21 CFR 890.3920 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for IML devices
openFDA lists no recalls for product code IML.
Frequently asked questions
What is FDA product code IML?
IML is the FDA product code for armrest, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel.
What device class is IML?
Class I, regulation 21 CFR 890.3920. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IML
- Run a recall and safety report across every IML manufacturer
- Watch product code IML 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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