IRE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Joint, Elbow, External Limb Component, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ELBOW PROSTHESIS (K822632) | Hosmer Dorrance Corp. | 1982-09-14 |
| UTAH ARTIFICAL ARM (K802642) | Motion Control, Inc. | 1980-11-12 |
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Every clearance here is in the API, with alerts when new ones post.