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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 K201845
Device Name Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
Guangzhou Longest Science & Technology Co., LTD.
5 & 6f, Building B4, No. 11, Kaiyuan Avenue, Science City
Guangzhou,  CN 510530
Applicant Contact Xiaobing Luo
Guangzhou KEDA Biological Tech Co., LTD.
6F, No. 1 TianTai Road, Science City, LuoGang District
Guangzhou,  CN
Correspondent Contact Jet Li
Regulation Number890.5850
Classification Product Code
Subsequent Product Codes
Date Received07/06/2020
Decision Date 10/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No