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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K254119
Device Name Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)
Applicant
Shenzhen Xinyan Medical Technology Co.,ltd.
1st Bldg.,501-1&501-2,Mitehua&Pukyo Bio Science Park
Jinxiu E. Rd.,Laokeng Comm.,Longtian St.,Pings Dist.
Shenzhen,  CN 518122
Applicant Contact Zhang Haibo
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number870.2800
Classification Product Code
MWJ  
Subsequent Product Code
DRG  
Date Received12/19/2025
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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