Device Dossier
Electrocardiographic long-term ambulatory recorder, telemetric
Device Dossier for Electrocardiographic long-term ambulatory recorder, telemetric (Electrocardiographic long-term ambulatory recorder, telemetric, Class…
Intended purpose
The S-Patch Ex wearable ECG patch is an electrocardiography (ECG) and heart rate (HR) data recording device for use by healthcare professionals for continuous collection of the ECG and HR data at home and in healthcare settings.The device is intended for use on general care patients who are 18 years of age or older for ECG and HR data collection purposes only. The data recorded by the S-Patch Ex wearable ECG patch can be uploaded wirelessly via a wellness app to a compatible 3rd party cloud-based ECG viewing platform for further analysis and interpretations by qualified clinicians.