IRN
11 FDA 510(k) clearances · Product code
112 daysmedian time to decision
254 days90th percentile
11clearances measured
FDA profile
- Official device name
- Device, Warning, Overload, External Limb, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5575
- Medical specialty
- Physical Medicine
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM (K060150) | Andante Medical Devices , Ltd. | 2006-02-23 |
| SMARTSTEP SYSTEM (K023161) | Andante Medical Device, Ltd. | 2002-12-10 |
| ACCUTRED SHOE (K991313) | Orthopedic Technology Research, Inc. | 1999-06-23 |
| FOOT WEIGHT ALARM (K962591) | Cleveland Medical Devices, Inc. | 1996-12-04 |
| INDEX SHOE (K960307) | Orthopedic Technology Research, Inc. | 1996-06-27 |
| FORCEGUARD (K955034) | Impact Monitors, Inc. | 1996-04-10 |
| PED ALERT (K950656) | Orbitec Technologies Corp. | 1995-10-25 |
| SAFE-STEP (K931517) | Lenjoy Engineering, Inc. | 1995-03-10 |
| FORCE GUARD I (K882974) | Boulder Impact Monitors, Inc. | 1988-11-04 |
| PELIMIT (K792241) | Colmed, Ltd. | 1979-11-30 |
| OVERLOAD WARNING DEVICE (K770405) | Synthes (Usa) | 1977-03-10 |
Track IRN automatically
Every clearance here is in the API, with alerts when new ones post.