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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 K200354
Device Name Electronic stimulator
Shenzhen Dongjilian Electronics Co.,Ltd.
B1/1-5F, Tonglu Industrial Area, Tongxin Community
Longgang District
Shenzhen,  CN 518116
Applicant Contact Zhang Hong
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 2012#, Gebu commercial building, Hongxing community,
Songgang street
Shenzhen,  CN 518105
Correspondent Contact Reanny Wang
Regulation Number882.5890
Classification Product Code
Date Received02/13/2020
Decision Date 06/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No