FDA product code IPX: Orthosis, Rib Fracture, Soft
IPX is the FDA product code for orthosis, rib fracture, soft. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel. FDA has cleared 3 510(k) submissions under IPX, from 2 different applicants. The average 510(k) review took 19 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Rib Fracture, 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 |
Compare with all 510(k) review times · Search every IPX clearance
Top IPX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warm & Form, Orthopedic Materials | 2 | 1982-12-30 |
| Danek Medical, Inc. | 1 | 1981-01-09 |
Most recent IPX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823662 | Warm & Form, Orthopedic Materials | RIB BELT (UNIVERSAL) | 1982-12-30 | 24 |
| K823158 | Warm & Form, Orthopedic Materials | RIB BELT (UNIVERSAL) | 1982-11-10 | 16 |
| K803239 | Danek Medical, Inc. | SOFTGOOD PRODUCTS AND SPLINTS | 1981-01-09 | 17 |
Recalls for IPX devices
openFDA lists no recalls for product code IPX.
Frequently asked questions
What is FDA product code IPX?
IPX is the FDA product code for orthosis, rib fracture, soft. It is a Class I device, regulated under 21 CFR 890.3490 and reviewed by the Physical Medicine panel.
What device class is IPX?
Class I, regulation 21 CFR 890.3490. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPX?
Across 3 cleared submissions the average was 19 days from receipt to decision (median 17).
Which companies have the most IPX clearances?
Warm & Form, Orthopedic Materials (2); Danek Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IPX
- Run a recall and safety report across every IPX manufacturer
- Watch product code IPX 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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