FDA product code IQC: Wheelchair, Special Grade
IQC is the FDA product code for wheelchair, special grade. It is a Class II device, regulated under 21 CFR 890.3880 and reviewed by the Physical Medicine panel. FDA has cleared 24 510(k) submissions under IQC, 1 in the last five years, from 14 different applicants. The average 510(k) review took 40 days (median 38); 32 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Wheelchair, Special Grade |
| Device class | Class II |
| Regulation | 21 CFR 890.3880 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IQC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 32 |
Top IQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Poirier S.A. | 10 | 1984-02-27 |
| Maddak, Inc. | 2 | 1977-02-02 |
| Vipamat Sarl | 1 | 2025-06-23 |
| Novaf Andalucia 2007, SL | 1 | 2012-07-06 |
| Alpha One | 1 | 2009-01-06 |
9 more applicants have IQC clearances. See the full list in Caduvo.
Most recent IQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251570 | Vipamat Sarl | Hippocampe Marathon and Trail | 2025-06-23 | 32 |
| K120302 | Novaf Andalucia 2007, SL | MECHANICAL WHEELCHAIR | 2012-07-06 | 156 |
| K082857 | Alpha One | RENEGADE WHEELCHAIR | 2009-01-06 | 99 |
| K051709 | Vipamat Technologie | HIPPOCAMPE WHEELCHAIR | 2005-08-15 | 49 |
| K895384 | Jubilee Scooters, Inc. | CALIFORNIA COMFORT FOUR WHEEL | 1989-09-18 | 19 |
Recalls for IQC devices
openFDA lists no recalls for product code IQC.
Frequently asked questions
What is FDA product code IQC?
IQC is the FDA product code for wheelchair, special grade. It is a Class II device, regulated under 21 CFR 890.3880 and reviewed by the Physical Medicine panel.
What device class is IQC?
Class II, regulation 21 CFR 890.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code IQC?
Across 24 cleared submissions the average was 40 days from receipt to decision (median 38).
Which companies have the most IQC clearances?
Poirier S.A. (10); Maddak, Inc. (2); Vipamat Sarl (1); Novaf Andalucia 2007, SL (1); Alpha One (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IQC
- Run a recall and safety report across every IQC manufacturer
- Watch product code IQC 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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