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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 K151722
Device Name Slim UP ULTRA
Applicant
Aime Medical, Inc.
1258 W. Bay Dr., Suite F
Largo,  FL  33770
Applicant Contact PAUL GUILBAUD
Correspondent
Ajw Technology Consultants, Inc.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact JOHN O'BRIEN
Regulation Number890.5850
Classification Product Code
NGX  
Date Received06/25/2015
Decision Date 03/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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