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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K182020
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 Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
NUH   NYN  
Date Received07/27/2018
Decision Date 09/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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