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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 K183674
Device Name Electronic Pulse Stimulator
Applicant
Shenzhen Leading Perfection Technology Co., Ltd
4th Floor, J Building, San Yi Dui Industrial Park, Zhoushi
Road, Jiuwei
Shenzhen,  CN 518101
Applicant Contact Simon Hou
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center,
Guimiao Road
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/27/2018
Decision Date 10/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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