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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 K220998
Device Name Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd.
2nd Floor No 11,Shanzhuang Road, Xikeng Village,
Yuanshan Street, Longgang District
Shenzhen,  CN 518100
Applicant Contact Zewu Zhang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center,
No. 3101-90, Qianhai Road
Shenzhen,  CN 518052
Correspondent Contact Yvonne Liu
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   IPF   NGX   NYN  
Date Received04/04/2022
Decision Date 08/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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