The following data is part of a premarket notification filed by Smartmissimo Technologies Pte Ltd with the FDA for Powerdot Pd-01mt2 Muscle Stimulator.
| Device ID | K210938 |
| 510k Number | K210938 |
| Device Name: | PowerDot PD-01MT2 Muscle Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Smartmissimo Technologies Pte Ltd #28-01, SGX Centre II, 4 Shenton Way Singapore, SG 068807 |
| Contact | Alexey Pisarev |
| Correspondent | Alexey Pisarev Smartmissimo Technologies Pte Ltd #28-01, SGX Centre II, 4 Shenton Way Singapore, SG 068807 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NUH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-07-30 |