Wearable ECG Recorder (8 models)— 510(k) K254119
Substantially EquivalentShenzhen Xinyan Medical Technology Co.,ltd.
FDA 510(k) clearance K254119 for Wearable ECG Recorder (8 models), Substantially Equivalent on 2026-09-11. Applicant: Shenzhen Xinyan Medical Technology Co.,ltd.. Device class: 2.
Summary
Eight models of the YMHeart wearable ECG recorder (the XY-12 and XY-03 families and their variants) cleared in one go under MWJ. That code covers ambulatory ECGs without analysis.
Class II, 21 CFR 870.2800. The Cardiovascular panel reviewed it as a Traditional 510(k).
Shenzhen Xinyan Medical Technology filed from Shenzhen, China. Review took 266 days (December 19, 2025 to September 11, 2026).
Clearance details
- Device name as filed
- 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.
- Product code
- Product code MWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code MWJ
view allAdverse events under product code MWJ
product code MWJ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.