510(k) K221443
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2022
- Date Received
- May 18, 2022
- Clearance Type
- Special
- 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