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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, Bldg. 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
Predetermined Change
Control Plan Authorized		 No
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