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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 K153520
Device Name Electronic Pulse Stimulator
Applicant
JKH HEALTH CO.,LTD.
4-5F, Building 12, Hengmingzhu Ind. Park,
Tongfuyu Ind. Area, Shajing, Baoan
shenzhen,  CN 518104
Applicant Contact pu jiang
Correspondent
BILL QUANQIN DAI
1142 S. DIAMOND BAR BLVD, #861
diamond bar,  CA  91765
Correspondent Contact bill quanqin dai
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received12/08/2015
Decision Date 05/05/2016
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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