FDA product code IMP: Cushion, Wheelchair
IMP is the FDA product code for cushion, 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 IMP, from 2 different applicants. The average 510(k) review took 16 days (median 16). FDA has posted 1 recall for IMP devices.
Classification
| Field | Value |
|---|---|
| Device name | Cushion, 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 IMP clearance
Top IMP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clark Pillow Co., Inc. | 1 | 1989-02-28 |
| Advantage Credit Services, Inc. | 1 | 1987-03-25 |
Most recent IMP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890653 | Clark Pillow Co., Inc. | ULTIMA WHEELCHAIR CUSHION | 1989-02-28 | 20 |
| K871006 | Advantage Credit Services, Inc. | EDCOOL AND EDCOOL JR. INSTANT COLD PACK | 1987-03-25 | 12 |
Recalls for IMP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-01-31.
Frequently asked questions
What is FDA product code IMP?
IMP is the FDA product code for cushion, wheelchair. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel.
What device class is IMP?
Class I, regulation 21 CFR 890.3920. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMP?
Across 2 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most IMP clearances?
Clark Pillow Co., Inc. (1); Advantage Credit Services, Inc. (1).
Have IMP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code IMP
- Run a recall and safety report across every IMP manufacturer
- Watch product code IMP 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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