FDA product code INF: Scale, Platform, Wheelchair
INF is the FDA product code for scale, platform, wheelchair. It is a Class I device, regulated under 21 CFR 890.3940 and reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under INF, from 4 different applicants. The average 510(k) review took 64 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Scale, Platform, Wheelchair |
| Device class | Class I |
| Regulation | 21 CFR 890.3940 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top INF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acme Medical Scale Co. | 2 | 1991-01-14 |
| U.S. Medical Corp. | 1 | 1993-02-12 |
| Medical Flotation Systems, Inc. | 1 | 1988-12-27 |
| Amigo Sales, Inc. | 1 | 1987-05-06 |
Most recent INF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924441 | U.S. Medical Corp. | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | 1993-02-12 | 164 |
| K910055 | Acme Medical Scale Co. | ACME MODEL 8500 WHEELCHAIR SCALE | 1991-01-14 | 7 |
| K884908 | Medical Flotation Systems, Inc. | ULTRAFLOTATION MEDICAL WHEELCHAIR | 1988-12-27 | 34 |
| K871391 | Amigo Sales, Inc. | AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED) | 1987-05-06 | 29 |
| K760327 | Acme Medical Scale Co. | WHEEL'N WEIGH | 1976-10-20 | 85 |
Recalls for INF devices
openFDA lists no recalls for product code INF.
Frequently asked questions
What is FDA product code INF?
INF is the FDA product code for scale, platform, wheelchair. It is a Class I device, regulated under 21 CFR 890.3940 and reviewed by the Physical Medicine panel.
What device class is INF?
Class I, regulation 21 CFR 890.3940. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INF?
Across 5 cleared submissions the average was 64 days from receipt to decision (median 34).
Which companies have the most INF clearances?
Acme Medical Scale Co. (2); U.S. Medical Corp. (1); Medical Flotation Systems, Inc. (1); Amigo Sales, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code INF
- Run a recall and safety report across every INF manufacturer
- Watch product code INF 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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