K220738 is an FDA 510(k) clearance for the Motive Knee Wrap. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Cymedica Orthopedics, Inc. (Tempe, US). The FDA issued a Cleared decision on May 12, 2022, 59 days after receiving the submission on March 14, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K220738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2022 |
| Decision Date | May 12, 2022 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |