FDA product code ISR: Band Or Belt, Pelvic Support
ISR is the FDA product code for band or belt, pelvic support. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ISR. The average 510(k) review took 13 days (median 13).
Classification
| Field | Value |
|---|---|
| Device name | Band Or Belt, Pelvic Support |
| 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 ISR clearance
Top ISR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 1 | 1979-02-08 |
Most recent ISR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790179 | Fred Sammons, Inc. | GAIR TRAINING BELT | 1979-02-08 | 13 |
Recalls for ISR devices
openFDA lists no recalls for product code ISR.
Frequently asked questions
What is FDA product code ISR?
ISR is the FDA product code for band or belt, pelvic support. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.
What device class is ISR?
Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ISR?
Across 1 cleared submissions the average was 13 days from receipt to decision (median 13).
Which companies have the most ISR clearances?
Fred Sammons, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ISR
- Run a recall and safety report across every ISR manufacturer
- Watch product code ISR 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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