GENERAL PURPOSE ELECTROCARDIOGRAPHS

Primary DI

D-8800159510000ZC

Basic UDI-DI Code

B-8800159510000ZC

Reference

S-Patch Ex

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Wellysis Corp.

The S-Patch Ex is a light-weight electrocardiogram (ECG) and heart rate (HR) monitoring device with accompanying software. The S-Patch Ex operates wirelessly, and due to compact size is unobtrusive during daily activity. The S-Patch Ex continuously measures ECG and HR signals, and streams digitized signals to a mobile gateway device equipped with the S-PATCH Ex App. At the end of each ECG recording session, patients can upload their data to a secure cloud portal via their mobile device connection. After data upload takes place, physicians can access and review their patients’ ECG data remotely via the S-Patch Ex App. The S-Patch Ex is intended to be used with direction from trained medical professionals in accordance with the user manual.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).