SWIVEL HEAD ADJUSTABLE CRUTCH
FDA 510(k) clearance K770146 · decided 1977-01-28
Clearance details
- K-number
- K770146
- Device name
- SWIVEL HEAD ADJUSTABLE CRUTCH
- Applicant
- Maddak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-01-24
- Decision date
- 1977-01-28
- Days to decision
- 4 days
- Clearance type
- Traditional
- Product code
- IPR
- Device class
- 1
- Regulation number
- 890.3150
- 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 |
|---|---|---|
| LIGHT WEIGHT ALUMINUM CRUTCHES (K821403) | Manuco Manufacturing Co., Inc. | 1982-06-21 |
| FOLDING CRUTCH (K800237) | Husa Folding Crutch Co., Inc. | 1980-02-22 |
| CRUTCH (K790557) | Maddak, Inc. | 1979-04-03 |
Recalls involving this device
No recalls on record reference this clearance.