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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 K182108
Device Name Portable Electro-Stimulation Therapy Device
Applicant
Guangzhou Longest Science & Technology Co., Ltd.
5&6f, Bldg. B4, #11, Kaiyuan Ave. Science City
Hi-Tech Industrial Zone
Guangzhou,  CN 510530
Applicant Contact Xiaobing Luo
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.1711, Bldg. K, #101 Science Ave.
International Creative Valley
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received08/03/2018
Decision Date 04/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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