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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 K182203
Device Name JKH Stimulator Plus
Applicant
Jkh USA, LLC
1142 S. Diamond Bar Blvd., #861
Diamond Bar,  CA  91765
Applicant Contact Bill Quanqin Dai
Correspondent
Jkh USA, LLC
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
GZI   GZJ   IPF   IRT   NGX  
NYN  
Date Received08/15/2018
Decision Date 03/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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