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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 K242332
Device Name Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd.
2nd Floor, # 11, Shanzhuang Rd., Xikeng Village
Yuanshan St., Longgang District
Shenzhen,  CN 518103
Applicant Contact Zewu Zhang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Rm. 2231, Bldg. 1, Ruifeng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received08/07/2024
Decision Date 11/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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