K210269 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 February 23, 2021, 22 days after receiving the submission on February 1, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K210269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2021 |
| Decision Date | February 23, 2021 |
| Days to Decision | 22 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 |