510(k) K190269
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2019
- Date Received
- February 8, 2019
- 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