Panels › Physical Medicine › Product code IRN · Class 2
Device, Warning, Overload, External Limb, Powered
Regulation 890.5575
0510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in IRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthopedic Technology Research, Inc. | 2 | 0 |
| Andante Medical Device, Ltd. | 1 | 0 |
| Andante Medical Devices , Ltd. | 1 | 0 |
| Boulder Impact Monitors, Inc. | 1 | 0 |
| Cleveland Medical Devices, Inc. | 1 | 0 |
| Colmed, Ltd. | 1 | 0 |
| Impact Monitors, Inc. | 1 | 0 |
| Lenjoy Engineering, Inc. | 1 | 0 |
| Orbitec Technologies Corp. | 1 | 0 |
| Synthes (Usa) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2006 | K060150 | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM Andante Medical Devices , Ltd., IL | IRN |
| Dec 10, 2002 | K023161 | SMARTSTEP SYSTEM Andante Medical Device, Ltd., IL | IRN |
| Jun 23, 1999 | K991313 | ACCUTRED SHOE Orthopedic Technology Research, Inc. | IRN |
| Dec 4, 1996 | K962591 | FOOT WEIGHT ALARM Cleveland Medical Devices, Inc. | IRN |
| Jun 27, 1996 | K960307 | INDEX SHOE Orthopedic Technology Research, Inc. | IRN |
| Apr 10, 1996 | K955034 | FORCEGUARD Impact Monitors, Inc. | IRN |
| Oct 25, 1995 | K950656 | PED ALERT Orbitec Technologies Corp. | IRN |
| Mar 10, 1995 | K931517 | SAFE-STEP Lenjoy Engineering, Inc. | IRN |
| Nov 4, 1988 | K882974 | FORCE GUARD I Boulder Impact Monitors, Inc. | IRN |
| Nov 30, 1979 | K792241 | PELIMIT Colmed, Ltd. | IRN |
| Mar 10, 1977 | K770405 | OVERLOAD WARNING DEVICE Synthes (Usa) | IRN |
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