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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 Plz., 837-26 Yeuksam-Dong
Gangnam-Gu,  KR 135-768
Applicant Contact YANG HO DONG
Correspondent
Miga Medical Co., Ltd.
#821 Samil Plz., 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
Predetermined Change
Control Plan Authorized		 No
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