RIB BELT (UNIVERSAL)
FDA 510(k) clearance K823662 · decided 1982-12-30
Clearance details
- K-number
- K823662
- Device name
- RIB BELT (UNIVERSAL)
- Applicant
- Warm & Form, Orthopedic Materials
- Decision
- Substantially Equivalent
- Date received
- 1982-12-06
- Decision date
- 1982-12-30
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- IPX
- Device class
- 1
- Regulation number
- 890.3490
- 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 |
|---|---|---|
| RIB BELT (UNIVERSAL) (K823158) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| SOFTGOOD PRODUCTS AND SPLINTS (K803239) | Danek Medical, Inc. | 1981-01-09 |
Recalls involving this device
No recalls on record reference this clearance.