ROTATION BOOT
FDA 510(k) clearance K823160 · decided 1982-11-10
Clearance details
- K-number
- K823160
- Device name
- ROTATION BOOT
- Applicant
- Warm & Form, Orthopedic Materials
- Decision
- Substantially Equivalent
- Date received
- 1982-10-25
- Decision date
- 1982-11-10
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- IQI
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, US
- 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 |
|---|---|---|
| Neurosplint (K143458) | Neurospectrum, LLC | 2015-08-13 |
| SENSOR WALK (K052771) | Otto Bock Healthcare LP | 2006-05-03 |
| SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576) | Surgitech, Inc. | 2003-07-31 |
| ACCUFLEX DYNAMIC ELBOW ORTHOSIS (K926391) | Regulatory & Marketing Services, Inc. | 1993-07-22 |
| MCCONNELL SHOULDER BRACE (K910974) | Mcconnell Orthopedic | 1991-03-21 |
| GAIT-AID ORTHOPEDIC INSOLE (K874502) | Gait-Aid, Inc. | 1987-11-30 |
| ADJUSTABLE POLYCENTRIC ELBOW HINGE (K831542) | Fred Sammons, Inc. | 1983-06-24 |
| DROP FOOT BRACE (K831615) | Edward Dilauro, Jr. | 1983-06-15 |
| VARIOUS SUPPORTS AND SPLINTS (K823812) | Danek Medical, Inc. | 1983-01-14 |
| BRACE-UP ALL PURPOSE WRIST BAND (K823113) | Arco Matic, Inc. | 1982-11-16 |
| BRACE-UP STOCKING KNEE BRACE (K823114) | Arco Matic, Inc. | 1982-11-05 |
| UNIVERSAL DYNASPLINT (K822767) | Dynasplint Systems, Inc. | 1982-10-06 |
Recalls involving this device
No recalls on record reference this clearance.