K951717 is an FDA 510(k) clearance for the MED-TEC KNEE CRUTCH. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on June 28, 1995, 76 days after receiving the submission on April 13, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K951717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1995 |
| Decision Date | June 28, 1995 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |