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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 K182671
Device Name Medi-Direct TENS Pen
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 Code
NYN  
Date Received09/26/2018
Decision Date 09/21/2019
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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