FDA product code IMY: Armboard, Wheelchair
IMY is the FDA product code for armboard, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel. Devices under IMY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Armboard, Wheelchair |
| Device class | Class I |
| Regulation | 21 CFR 890.3910 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IMY devices
openFDA lists no recalls for product code IMY.
Frequently asked questions
What is FDA product code IMY?
IMY is the FDA product code for armboard, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel.
What device class is IMY?
Class I, regulation 21 CFR 890.3910. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IMY
- Run a recall and safety report across every IMY manufacturer
- Watch product code IMY 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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