K821403 is an FDA 510(k) clearance for the LIGHT WEIGHT ALUMINUM CRUTCHES. This device is classified as a Crutch (Class I - General Controls, product code IPR).
Submitted by Manuco Manufacturing Co., Inc. (Walker, US). The FDA issued a Cleared decision on June 21, 1982, 41 days after receiving the submission on May 11, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3150.
| 510(k) Number | K821403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1982 |
| Decision Date | June 21, 1982 |
| Days to Decision | 41 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 |