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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 Bldg., # 71, Xintian Rd., Fuyong St., Baoan
Shenzhen,  CN 518100
Applicant Contact Tom Tom
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd.
Rm. 2012#, Gebu Commercial Bldg., Hongxing Community,
Songgang St.
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
Predetermined Change
Control Plan Authorized		 No
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