K210938 is an FDA 510(k) clearance for the PowerDot PD-01MT2 Muscle Stimulator. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Smartmissimo Technologies Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 30, 2021, 123 days after receiving the submission on March 29, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K210938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2021 |
| Decision Date | July 30, 2021 |
| Days to Decision | 123 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |