IRA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hand, External Limb Component, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3420
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| THE SPORTS HAND (K821619) | Therapeutic Recreation Systems, Inc. | 1982-07-20 | + Add |
| PREHENSILE HAND (K791931) | Therapeutic Recreation Systems, Inc. | 1979-10-04 | + Add |
Track IRA automatically
Every clearance here is in the API, with alerts when new ones post.