Clearance Summary
PowerDot PD-01MT2 Muscle Stimulator received FDA 510(k) clearance under submission number K210269, sponsored by Smartmissimo Technologies Pte, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2021-02-23.
- Submission: K210269
- Applicant / Sponsor: Smartmissimo Technologies Pte, Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2021-02-23
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.