510(k) K191951
K191951 is an FDA 510(k) premarket notification submitted by Avazzia, Inc. for the device "Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device". The FDA issued a decision of Substantially Equivalent on Apr 27, 2021. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Avazzia, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 2021
- Date Received
- Jul 22, 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
- 510(k)