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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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