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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K151955
Device Name YuGo System
Applicant
BIOGAMING LTD.
HAMGSHIMIM 20
PETACH TIKVA,  IL 4934829
Applicant Contact RONIT HARPAZ
Correspondent
DUET MEDICAL CONSULTING LTD.
10TH HAANAFA ST.
ZUR MOSHE,  IL 4281000
Correspondent Contact VERED NITZAN
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received07/15/2015
Decision Date 02/05/2016
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 No
Predetermined Change
Control Plan Authorized		 No
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