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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 K150995
Device Name Electronic Pulse Stimulator
Applicant
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD
5F, BUILDING 12, HENGMINGZHU INDUSTRIAL PARK, XIANGXING ROAD
SHAJING, BAOAN
SHENZHEN,  CN 518104
Applicant Contact PU JIANG
Correspondent
BILL QUANQIN DAI
23541 COYOTE SPRING DRIVE
DIAMOND BAR,  CA  91765
Correspondent Contact BILL QUANQIN DAI
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received04/15/2015
Decision Date 07/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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