510(k) K192733
K192733 is an FDA 510(k) premarket notification submitted by Umeheal , Ltd. for the device "RelieforMe TENS/EMS Device Model UPK-GE01". The FDA issued a decision of Substantially Equivalent on Dec 23, 2019. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 23, 2019
- Date Received
- Sep 27, 2019
- Clearance Type
- Traditional
- 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)