FDA product code ITS: Joint, Hip, External Brace
ITS is the FDA product code for joint, hip, external brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ITS. The average 510(k) review took 13 days (median 13).
Classification
| Field | Value |
|---|---|
| Device name | Joint, Hip, External Brace |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| 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 ITS clearance
Top ITS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hosmer Dorrance Corp. | 1 | 1978-06-13 |
Most recent ITS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780891 | Hosmer Dorrance Corp. | POST-OPERATIVE HIP ORTHOSIS | 1978-06-13 | 13 |
Recalls for ITS devices
openFDA lists no recalls for product code ITS.
Frequently asked questions
What is FDA product code ITS?
ITS is the FDA product code for joint, hip, external brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is ITS?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITS?
Across 1 cleared submissions the average was 13 days from receipt to decision (median 13).
Which companies have the most ITS clearances?
Hosmer Dorrance Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ITS
- Run a recall and safety report across every ITS manufacturer
- Watch product code ITS 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.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times