K770146 is an FDA 510(k) clearance for the SWIVEL HEAD ADJUSTABLE CRUTCH. This device is classified as a Crutch (Class I - General Controls, product code IPR).
Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1977, 4 days after receiving the submission on January 24, 1977.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3150.
| 510(k) Number | K770146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1977 |
| Decision Date | January 28, 1977 |
| Days to Decision | 4 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPR — Crutch |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3150 |