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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 K130150
Device Name TCM MASSAGER
Applicant
Anhui Jinjianqiao Med-Tech Co,. , Ltd.
05c.Fuhai Kangle Bldg.
Nanshan District Shenzhen
Shenzhen, Guangdong,  CN 518000
Applicant Contact FIELD FU
Correspondent
Anhui Jinjianqiao Med-Tech Co,. , Ltd.
05c.Fuhai Kangle Bldg.
Nanshan District Shenzhen
Shenzhen, Guangdong,  CN 518000
Correspondent Contact FIELD FU
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received01/22/2013
Decision Date 09/26/2013
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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