FDA product code INM: Chair, With Casters
INM is the FDA product code for chair, with casters. It is a Class I device, regulated under 21 CFR 890.3100 and reviewed by the Physical Medicine panel. FDA has cleared 35 510(k) submissions under INM, from 30 different applicants. The average 510(k) review took 50 days (median 22). FDA has posted 25 recalls for INM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Chair, With Casters |
| Device class | Class I |
| Regulation | 21 CFR 890.3100 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every INM clearance
Top INM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Winco, Inc. | 2 | 1994-04-26 |
| Theradapt Products, Inc. | 2 | 1993-03-24 |
| Daun International, Inc. | 2 | 1985-07-09 |
| Maddak, Inc. | 2 | 1984-05-11 |
| Winco Winfield Co., Inc. | 2 | 1980-11-19 |
25 more applicants have INM clearances. See the full list in Caduvo.
Most recent INM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063521 | Nissin Medical, Inc. | NISSIN PEDIATRIC SERIES WHEELCHAIR | 2007-02-05 | 75 |
| K941738 | Stryker Medical | STRYKER 5050 STRECHAIR | 1994-05-06 | 29 |
| K941569 | Winco, Inc. | CAREMOR CLINER | 1994-04-26 | 26 |
| K933000 | Winco, Inc. | RECLINING GERI CHAIRS W/CASTERS & LAP TRAY | 1993-09-30 | 104 |
| K926028 | Theradapt Products, Inc. | BENCHES | 1993-03-24 | 161 |
Recalls for INM devices
25 product recalls in 12 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2021-11-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 4 |
Frequently asked questions
What is FDA product code INM?
INM is the FDA product code for chair, with casters. It is a Class I device, regulated under 21 CFR 890.3100 and reviewed by the Physical Medicine panel.
What device class is INM?
Class I, regulation 21 CFR 890.3100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INM?
Across 35 cleared submissions the average was 50 days from receipt to decision (median 22).
Which companies have the most INM clearances?
Winco, Inc. (2); Theradapt Products, Inc. (2); Daun International, Inc. (2); Maddak, Inc. (2); Winco Winfield Co., Inc. (2).
Have INM devices been recalled?
Yes: 25 product recalls across 12 recall events; the most recent began 2021-11-19.
Next steps
- Run an FDA pathway report with predicate devices for product code INM
- Run a recall and safety report across every INM manufacturer
- Watch product code INM 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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