FDA product code IRA: Hand, External Limb Component, Mechanical
IRA is the FDA product code for hand, external limb component, mechanical. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under IRA. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Hand, External Limb Component, Mechanical |
| Device class | Class I |
| Regulation | 21 CFR 890.3420 |
| 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 IRA clearance
Top IRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Therapeutic Recreation Systems, Inc. | 2 | 1982-07-20 |
Most recent IRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821619 | Therapeutic Recreation Systems, Inc. | THE SPORTS HAND | 1982-07-20 | 48 |
| K791931 | Therapeutic Recreation Systems, Inc. | PREHENSILE HAND | 1979-10-04 | 7 |
Recalls for IRA devices
openFDA lists no recalls for product code IRA.
Frequently asked questions
What is FDA product code IRA?
IRA is the FDA product code for hand, external limb component, mechanical. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is IRA?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IRA?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most IRA clearances?
Therapeutic Recreation Systems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code IRA
- Run a recall and safety report across every IRA manufacturer
- Watch product code IRA 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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