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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 K182871
Device Name Mini TENS Therapy Device
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
D Building, No. 71, Xintian Road, Fuyong Street, Baoan,
Shenzhen,  CN 518100
Applicant Contact Tom Tom
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 2012#,Gebu commercial building, Hongxing community,
Songgang street,
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number882.5890
Classification Product Code
NUH  
Date Received10/12/2018
Decision Date 08/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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