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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 K133965
Device Name OTC EMS STIMULATOR
Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
No. 3 Building XiliBaimang Xusheng Industrial Estate
Nanshan
SHENZHEN,  CN 518108
Applicant Contact QILIAN LIU
Correspondent
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
No. 3 Building XiliBaimang Xusheng Industrial Estate
Nanshan
SHENZHEN,  CN 518108
Correspondent Contact QILIAN LIU
Regulation Number890.5850
Classification Product Code
NGX  
Date Received12/24/2013
Decision Date 06/16/2014
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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