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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 WEST BAY DRIVE, 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
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