MEMO Patch M (MPT-E08R-UNC01)

The MEMO Patch M is a wearable electrocardiogram (ECG) recording patch designed for continuous, long-term ambulatory monitoring of heart rhythm. It records single-channel ECG data via a battery-powered patch worn on the upper left chest, stores the data internally, and transfers it to a PC via USB for manual review by healthcare professionals. The device is prescription-use only and is intended to supplement other patient data without providing automated analysis or detection of specific cardiac conditions.

The MEMO Patch M uses USB transmission to transfer ECG data to a PC, whereas the predicate V-Patch Cardiac Monitor uses Bluetooth transmission. Both devices share identical sampling rate (250 Hz), anatomical site (chest), use of off-the-shelf disposable electrodes, reusable electronic units, replaceable batteries, moderate software concern level, and lack of real-time ECG viewing or arrhythmia alarms. Both are designed for ambulatory long-term continuous ECG monitoring with manual interpretation only.

The device underwent testing per ISO 10993-1:2018 (biocompatibility), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), and IEC 60601-2-47:2015 (ambulatory ECG systems). Software verification and validation testing was also performed.

The MEMO Patch M is substantially equivalent to the predicate V-Patch Cardiac Monitor because both devices have identical intended use, physical characteristics, technological characteristics, product code (DXH), regulatory classification (Class II), and clinical application for manual ECG review. The difference in transmission method (USB vs. Bluetooth) does not raise different safety or effectiveness questions, as both achieve the same functional outcome of transferring ECG data for professional review.