K181759 is an FDA 510(k) clearance for the PowerDot PD-01MT. 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 November 9, 2018, 130 days after receiving the submission on July 2, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K181759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2018 |
| Decision Date | November 09, 2018 |
| Days to Decision | 130 days |
| Submission Type | Abbreviated |
| 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 |