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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 K183288
Device Name Transcutaneous Electrical Nerve Stimulator
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd.
#3, Xihu Industry Zone, Xikeng Village, Henggang Town
Longgang District
Shenzhen,  CN 518115
Applicant Contact Zewu Zhang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
B-3f-3005, Bldg.1, Southward Ruifeng Business Center, #22
Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Tracy Che
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received11/26/2018
Decision Date 07/30/2019
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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