FDA product code IMO: Handrim, Wheelchair
IMO is the FDA product code for handrim, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel. Devices under IMO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Handrim, 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 IMO devices
openFDA lists no recalls for product code IMO.
Frequently asked questions
What is FDA product code IMO?
IMO is the FDA product code for handrim, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel.
What device class is IMO?
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 IMO
- Run a recall and safety report across every IMO manufacturer
- Watch product code IMO 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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