← Product Code [MWJ](/productcode/MWJ) · K254119

# 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) (K254119)

_Shenzhen Xinyan Medical Technology Co.,ltd. · MWJ · Sep 11, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K254119

## Device Facts

- **Applicant:** Shenzhen Xinyan Medical Technology Co.,ltd.
- **Product Code:** [MWJ](/productcode/MWJ.md)
- **Decision Date:** Sep 11, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2800
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

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**Source:** [https://fda.innolitics.com/device/K254119](https://fda.innolitics.com/device/K254119)

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