FDA product code IQP: Rotator, Transverse
IQP is the FDA product code for rotator, transverse. 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 IQP. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Rotator, Transverse |
| 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 IQP clearance
Top IQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Parke-Davis Co. | 1 | 1979-01-08 |
Most recent IQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K782148 | Parke-Davis Co. | HR UNIT | 1979-01-08 | 17 |
Recalls for IQP devices
openFDA lists no recalls for product code IQP.
Frequently asked questions
What is FDA product code IQP?
IQP is the FDA product code for rotator, transverse. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.
What device class is IQP?
Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IQP?
Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most IQP clearances?
Parke-Davis Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IQP
- Run a recall and safety report across every IQP manufacturer
- Watch product code IQP 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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