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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 K222870
Device Name Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd.
2nd Floor No 11, Shanzhuang Rd., Xikeng Village,
Yuanshan St., Longgang District
Shenzhen,  CN 518100
Applicant Contact Zewu Zhang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Yvonne Liu
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   IPF   NGX   NYN  
Date Received09/22/2022
Decision Date 05/10/2023
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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