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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K130802
Device Name OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
XILIXIAOBAIMANG
SHENZHEN, GUANGDONG,  CN 518108
Applicant Contact JIANPING KANG
Correspondent
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
XILIXIAOBAIMANG
SHENZHEN, GUANGDONG,  CN 518108
Correspondent Contact JIANPING KANG
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received03/22/2013
Decision Date 09/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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