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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K152420
Device Name AK Body Toning Device
Applicant
Ak Beauty Enterprises, LLC
436 N. Bedford Dr.
Suite 203
Beverly Hills,  CA  90210
Applicant Contact Robert Applebaum
Correspondent
Benjamin L. England and Associates, LLC
810 Landmark Dr. Suite 126
Glen Burnie,  MD  21061
Correspondent Contact Thomas C. Knott
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/26/2015
Decision Date 12/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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