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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 K141260
Device Name ELECTRONIC PULSE STIMULATOR
Applicant
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
513 PIAZZA DR.
UNIT B
MOUNTAIN VIEW,  CA  94043
Applicant Contact BILL QUANQIN DAI
Correspondent
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
513 PIAZZA DR.
UNIT B
MOUNTAIN VIEW,  CA  94043
Correspondent Contact BILL QUANQIN DAI
Regulation Number882.5890
Classification Product Code
NUH  
Date Received05/15/2014
Decision Date 09/17/2014
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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