FDA product code IMM: Footrest, Wheelchair
IMM is the FDA product code for footrest, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under IMM, from 2 different applicants. The average 510(k) review took 72 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Footrest, Wheelchair |
| Device class | Class I |
| Regulation | 21 CFR 890.3920 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IMM clearance
Top IMM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Union Industrial Co., Ltd. | 1 | 1989-08-24 |
| Fred Sammons, Inc. | 1 | 1982-06-11 |
Most recent IMM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K892791 | Union Industrial Co., Ltd. | PATIENT EXAMINATION GLOVES (LATEX) | 1989-08-24 | 135 |
| K821634 | Fred Sammons, Inc. | EZ STAND MOBILE STOOL | 1982-06-11 | 8 |
Recalls for IMM devices
openFDA lists no recalls for product code IMM.
Frequently asked questions
What is FDA product code IMM?
IMM is the FDA product code for footrest, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel.
What device class is IMM?
Class I, regulation 21 CFR 890.3920. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMM?
Across 2 cleared submissions the average was 72 days from receipt to decision (median 72).
Which companies have the most IMM clearances?
Union Industrial Co., Ltd. (1); Fred Sammons, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IMM
- Run a recall and safety report across every IMM manufacturer
- Watch product code IMM 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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