PREHENSILE HAND
FDA 510(k) clearance K791931 · decided 1979-10-04
Clearance details
- K-number
- K791931
- Device name
- PREHENSILE HAND
- Applicant
- Therapeutic Recreation Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-09-27
- Decision date
- 1979-10-04
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- IRA
- Device class
- 1
- Regulation number
- 890.3420
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, 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 |
|---|---|---|
| THE SPORTS HAND (K821619) | Therapeutic Recreation Systems, Inc. | 1982-07-20 |
Recalls involving this device
No recalls on record reference this clearance.