SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
FDA 510(k) clearance K060150 · decided 2006-02-23
Clearance details
- K-number
- K060150
- Device name
- SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
- Applicant
- Andante Medical Devices , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-20
- Decision date
- 2006-02-23
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- IRN
- Device class
- 2
- Regulation number
- 890.5575
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Ramat Gan, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.