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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 K143059
Device Name TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator)
Applicant
TONE-A-MATIC INTERNATIONAL INC.
145 TRADERS BLVD EAST, UNIT 18
MISSISSAUGA,  CA L4Z-3L3
Applicant Contact MANUEL CHUCK
Correspondent
TONE-A-MATIC INTERNATIONAL INC.
145 TRADERS BLVD EAST, UNIT 18
MISSISSAUGA,  CA L4Z-3L3
Correspondent Contact MANUEL CHUCK
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received10/24/2014
Decision Date 01/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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