LIGHT WEIGHT ALUMINUM CRUTCHES
FDA 510(k) clearance K821403 · decided 1982-06-21
Clearance details
- K-number
- K821403
- Device name
- LIGHT WEIGHT ALUMINUM CRUTCHES
- Applicant
- Manuco Manufacturing Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-11
- Decision date
- 1982-06-21
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- IPR
- Device class
- 1
- Regulation number
- 890.3150
- 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 |
|---|---|---|
| FOLDING CRUTCH (K800237) | Husa Folding Crutch Co., Inc. | 1980-02-22 |
| CRUTCH (K790557) | Maddak, Inc. | 1979-04-03 |
| SWIVEL HEAD ADJUSTABLE CRUTCH (K770146) | Maddak, Inc. | 1977-01-28 |
Recalls involving this device
No recalls on record reference this clearance.