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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electro-Acupuncture
510(k) Number K130768
Device Name JIAJIAN CMN STIMULATOR
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd.
Rm. 1706, # 128 Songle Rd.
Songjiang Area
Shanghai,  CN 201600
Applicant Contact DORIS DONG
Correspondent
Wuxi Jiajian Medical Instrument Co., Ltd.
Rm. 1706, # 128 Songle Rd.
Songjiang Area
Shanghai,  CN 201600
Correspondent Contact DORIS DONG
Classification Product Code
BWK  
Date Received03/20/2013
Decision Date 08/16/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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