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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 K191151
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
GZJ   IPF   IRT   NGX   NYN  
Date Received05/01/2019
Decision Date 06/21/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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