DeviceClearance

Wearable ECG Recorder (8 models)— 510(k) K254119

Substantially Equivalent

Shenzhen 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: they record, and a clinician or separate software does the interpreting.

Class II, 21 CFR 870.2800. The Cardiovascular panel reviewed it as a Traditional 510(k).

Shenzhen Xinyan Medical Technology filed from Shenzhen, China. A 266-day clock (December 19, 2025 to September 11, 2026) is long for a recorder with no analysis of its own. Big multi-model filings tend to invite questions about whether the variants really are equivalent, on top of the usual electrical safety and wireless testing.

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
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
Download summary PDFView on FDA.gov ↗

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Adverse 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 →

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