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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 K131921
Device Name ELECTRONIC PULSE STIMULATOR
Applicant
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
513 PIAZZA DR.
UNIT B
MOUNTAIN VIEW,  CA  94043
Applicant Contact BILL DAI
Correspondent
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
513 PIAZZA DR.
UNIT B
MOUNTAIN VIEW,  CA  94043
Correspondent Contact BILL DAI
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received06/26/2013
Decision Date 11/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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