510(k) clearance
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)
- 510(k) number
- K254119
- Applicant
- Shenzhen Xinyan Medical Technology Co.,ltd.
- Decision date
- Sep 11, 2026
- Date received
- Dec 19, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MWJ
- Device type
- Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II
- Regulation
- 21 CFR 870.2800
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Shenzhen, CN