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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Rd., Suite 515
Dallas,  TX  75240
Applicant Contact Tammy Lahutsky
Correspondent
Avazzia, Inc.
13140 Coit Rd., Suite 515
Dallas,  TX  75240
Correspondent Contact Tammy Lahutsky
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
OHS  
Date Received07/22/2019
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
Predetermined Change
Control Plan Authorized		 No
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