FDA product code IQM: Splint, Temporary Training
IQM is the FDA product code for splint, temporary training. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under IQM, from 2 different applicants. The average 510(k) review took 19 days (median 10).
Classification
| Field | Value |
|---|---|
| Device name | Splint, Temporary Training |
| Device class | Class I |
| Regulation | 21 CFR 890.3025 |
| 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 IQM clearance
Top IQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 2 | 1977-05-26 |
| Fred Sammons, Inc. | 1 | 1977-07-21 |
Most recent IQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771287 | Fred Sammons, Inc. | FINGEO EXTENSION SPLINTS | 1977-07-21 | 38 |
| K770891 | Orthopedic Systems, Inc. | SPLINH, FOREARM | 1977-05-26 | 10 |
| K770890 | Orthopedic Systems, Inc. | SPLINT, COCKUP | 1977-05-26 | 10 |
Recalls for IQM devices
openFDA lists no recalls for product code IQM.
Frequently asked questions
What is FDA product code IQM?
IQM is the FDA product code for splint, temporary training. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.
What device class is IQM?
Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQM?
Across 3 cleared submissions the average was 19 days from receipt to decision (median 10).
Which companies have the most IQM clearances?
Orthopedic Systems, Inc. (2); Fred Sammons, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IQM
- Run a recall and safety report across every IQM manufacturer
- Watch product code IQM 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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