FDA product code IRE: Joint, Elbow, External Limb Component, Powered
IRE is the FDA product code for joint, elbow, external limb component, powered. 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 IRE, from 2 different applicants. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Joint, Elbow, External Limb Component, Powered |
| 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 |
Top IRE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hosmer Dorrance Corp. | 1 | 1982-09-14 |
| Motion Control, Inc. | 1 | 1980-11-12 |
Most recent IRE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822632 | Hosmer Dorrance Corp. | ELBOW PROSTHESIS | 1982-09-14 | 14 |
| K802642 | Motion Control, Inc. | UTAH ARTIFICAL ARM | 1980-11-12 | 19 |
Recalls for IRE devices
openFDA lists no recalls for product code IRE.
Frequently asked questions
What is FDA product code IRE?
IRE is the FDA product code for joint, elbow, external limb component, powered. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is IRE?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IRE?
Across 2 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most IRE clearances?
Hosmer Dorrance Corp. (1); Motion Control, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IRE
- Run a recall and safety report across every IRE manufacturer
- Watch product code IRE 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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