FDA Product Code
FDA Product Code IRN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5575
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K060150 | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM | Andante Medical Devices , Ltd. | 2006-02-23 | Special | PDF ↗ |
| K023161 | SMARTSTEP SYSTEM | Andante Medical Device, Ltd. | 2002-12-10 | Traditional | PDF ↗ |
| K991313 | ACCUTRED SHOE | Orthopedic Technology Research, Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K962591 | FOOT WEIGHT ALARM | Cleveland Medical Devices, Inc. | 1996-12-04 | Traditional | PDF ↗ |
| K960307 | INDEX SHOE | Orthopedic Technology Research, Inc. | 1996-06-27 | Traditional | PDF ↗ |
| K955034 | FORCEGUARD | Impact Monitors, Inc. | 1996-04-10 | Traditional | PDF ↗ |
| K950656 | PED ALERT | Orbitec Technologies Corp. | 1995-10-25 | Traditional | PDF ↗ |
| K931517 | SAFE-STEP | Lenjoy Engineering, Inc. | 1995-03-10 | Traditional | PDF ↗ |
| K882974 | FORCE GUARD I | Boulder Impact Monitors, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K792241 | PELIMIT | Colmed, Ltd. | 1979-11-30 | Traditional | PDF ↗ |
| K770405 | OVERLOAD WARNING DEVICE | Synthes (Usa) | 1977-03-10 | Traditional | PDF ↗ |
Product code IRN · Class II · Physical Medicine. Data: openFDA.