FDA product code IQF: Orthosis, Cervical-Thoracic, Rigid
IQF is the FDA product code for orthosis, cervical-thoracic, rigid. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 7 510(k) submissions under IQF, from 5 different applicants. The average 510(k) review took 20 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Cervical-Thoracic, Rigid |
| Device class | Class I |
| Regulation | 21 CFR 890.3490 |
| 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 IQF clearance
Top IQF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthomedics | 3 | 1983-09-20 |
| Zee Medical Products Co., Inc. | 1 | 1981-09-21 |
| Hospital Products Co. | 1 | 1979-08-03 |
| Medi-Ked, Inc. | 1 | 1978-10-27 |
| Marullo, Baldwin, Frieden, Gatewood, | 1 | 1978-04-12 |
Most recent IQF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832741 | Orthomedics | JASON CERVICAL ORTHOSIS | 1983-09-20 | 36 |
| K812342 | Zee Medical Products Co., Inc. | ZEE EXTRICATION DEVICE | 1981-09-21 | 34 |
| K811297 | Orthomedics | CERVICAL SUPPORT | 1981-05-27 | 16 |
| K810555 | Orthomedics | SCOLIOSIS ORTHOTIC SYSTEM | 1981-03-13 | 11 |
| K791350 | Hospital Products Co. | POPE AMBULATORY HALO VEST | 1979-08-03 | 17 |
Recalls for IQF devices
openFDA lists no recalls for product code IQF.
Frequently asked questions
What is FDA product code IQF?
IQF is the FDA product code for orthosis, cervical-thoracic, rigid. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IQF?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQF?
Across 7 cleared submissions the average was 20 days from receipt to decision (median 16).
Which companies have the most IQF clearances?
Orthomedics (3); Zee Medical Products Co., Inc. (1); Hospital Products Co. (1); Medi-Ked, Inc. (1); Marullo, Baldwin, Frieden, Gatewood, (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IQF
- Run a recall and safety report across every IQF manufacturer
- Watch product code IQF 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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