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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 K230443
Device Name TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
Applicant
Jiangxi Royall Smart Technology Co., Ltd.
Workshop 3#, Shangyou Lefeng Technology Co., Ltd.,
Huangbu Town
Ganzhou,  CN 341200
Applicant Contact Shunzhou Yang
Correspondent
Share Info (Guangzhou) Medical Consultant Ltd.
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received02/21/2023
Decision Date 05/22/2023
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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