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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 K170205
Device Name Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
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
Shenzhen Kentro Medical Electronics Co., Ltd.
#3, Xihu Industry Zone, Xikeng Village, Henggang Town
Longgang District
Shenzhen,  CN 518115
Correspondent Contact Tracy Che
Regulation Number882.5890
Classification Product Code
NUH  
Date Received01/23/2017
Decision Date 05/11/2017
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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