510(k) K210938
K210938 is an FDA 510(k) premarket notification submitted by Smartmissimo Technologies Pte, Ltd. for the device "PowerDot PD-01MT2 Muscle Stimulator". The FDA issued a decision of Substantially Equivalent on Jul 30, 2021. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Smartmissimo Technologies Pte, Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 2021
- Date Received
- Mar 29, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)