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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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