510(k) K213078
K213078 is an FDA 510(k) premarket notification submitted by Johari Digital Healthcare Limited for the device "Myolift QT". The FDA issued a decision of Substantially Equivalent on Apr 27, 2023. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Johari Digital Healthcare Limited has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 2023
- Date Received
- Sep 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
- 510(k)