Device Classification Name |
stimulator, transcutaneous electrical, aesthetic purposes
|
510(k) Number |
K191951 |
Device Name |
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device |
Applicant |
Avazzia, Inc |
13140 Coit Road, Suite 515 |
Dallas,
TX
75240
|
|
Applicant Contact |
Tammy Lahutsky |
Correspondent |
Avazzia, Inc |
13140 Coit Road, Suite 515 |
Dallas,
TX
75240
|
|
Correspondent Contact |
Tammy Lahutsky |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/22/2019 |
Decision Date | 04/27/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|