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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 K122393
Device Name TG-BODY MI&BODY S-TRAINER
Applicant
MIGA MEDICAL CO., LTD.
#821 SAMIL PLAZA
837-26 YEUKSAM-DONG
GANGNAM-GU,  KR 135-768
Applicant Contact YANG HO DONG
Correspondent
MIGA MEDICAL CO., LTD.
#821 SAMIL PLAZA
837-26 YEUKSAM-DONG
GANGNAM-GU,  KR 135-768
Correspondent Contact YANG HO DONG
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/07/2012
Decision Date 12/10/2013
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 No
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