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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K221589
Device Name Starly pad
Applicant
Shenzhen Xingyuanli Technology Co., Ltd.
4/F, #1, Tianshida Industrial Park, #79 Longwo Rd.,
Kengzi St., Pingshan New District
Zhezhen,  CN 518110
Applicant Contact Tse Adrian
Correspondent
Shenzhen Xingyuanli Technology Co., Ltd.
4/F, #1, Tianshida Industrial Park, #79 Longwo Rd.,
Kengzi St., Pingshan New District
Zhezhen,  CN 518110
Correspondent Contact Tse Adrian
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/01/2022
Decision Date 03/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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