K192746 is an FDA 510(k) clearance for the MyoWorx TM20. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Myoworx, Inc. (Guelph, CA). The FDA issued a Cleared decision on October 19, 2021, 750 days after receiving the submission on September 30, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K192746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2019 |
| Decision Date | October 19, 2021 |
| Days to Decision | 750 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 |