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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 K110707
Device Name CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg., Xiliyiangguang
Industrial Estate Xilxiaobaima
Shenzhen Guangdong,  CN 518108
Applicant Contact KANG JIAN PING
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
# 3 Bldg., Xiliyiangguang
Industrial Estate Xilxiaobaima
Shenzhen Guangdong,  CN 518108
Correspondent Contact KANG JIAN PING
Regulation Number882.5890
Classification Product Code
NUH  
Date Received03/14/2011
Decision Date 08/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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