FDA product code IPW: Orthosis, Sacroiliac, Soft
IPW is the FDA product code for orthosis, sacroiliac, soft. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under IPW. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Sacroiliac, Soft |
| 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 |
Top IPW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Tiggs Co. | 1 | 1981-05-15 |
Most recent IPW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811176 | The Tiggs Co. | TIGGES SPINAL | 1981-05-15 | 17 |
Recalls for IPW devices
openFDA lists no recalls for product code IPW.
Frequently asked questions
What is FDA product code IPW?
IPW is the FDA product code for orthosis, sacroiliac, soft. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IPW?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPW?
Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most IPW clearances?
The Tiggs Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IPW
- Run a recall and safety report across every IPW manufacturer
- Watch product code IPW 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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