The following data is part of a premarket notification filed by Manuco Manufacturing Co., Inc. with the FDA for Light Weight Aluminum Crutches.
| Device ID | K821403 |
| 510k Number | K821403 |
| Device Name: | LIGHT WEIGHT ALUMINUM CRUTCHES |
| Classification | Crutch |
| Applicant | MANUCO MANUFACTURING CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IPR |
| CFR Regulation Number | 890.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-11 |
| Decision Date | 1982-06-21 |