FDA product code IMX: Board, Lap, Wheelchair
IMX is the FDA product code for board, lap, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under IMX, from 2 different applicants. The average 510(k) review took 10 days (median 10).
Classification
| Field | Value |
|---|---|
| Device name | Board, Lap, 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 |
Compare with all 510(k) review times · Search every IMX clearance
Top IMX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Equipment Co., Inc. | 1 | 1978-02-13 |
| Fred Sammons, Inc. | 1 | 1978-01-05 |
Most recent IMX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780184 | Orthopedic Equipment Co., Inc. | WHEELCHAIR ACCESSORIES | 1978-02-13 | 10 |
| K772401 | Fred Sammons, Inc. | LAP BOARD W/RIM | 1978-01-05 | 9 |
Recalls for IMX devices
openFDA lists no recalls for product code IMX.
Frequently asked questions
What is FDA product code IMX?
IMX is the FDA product code for board, lap, wheelchair. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel.
What device class is IMX?
Class I, regulation 21 CFR 890.3910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMX?
Across 2 cleared submissions the average was 10 days from receipt to decision (median 10).
Which companies have the most IMX clearances?
Orthopedic Equipment Co., Inc. (1); Fred Sammons, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IMX
- Run a recall and safety report across every IMX manufacturer
- Watch product code IMX 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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