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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
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