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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
Original Applicant
MIGA MEDICAL CO., LTD.
#821 samil plaza
837-26 yeuksam-dong
gangnam-gu,  KS 135-768
Original Contact yang ho dong
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/23/2012
Decision Date 12/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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