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 intended use of the Rooti Rx System records single-channel or three-channel ECG data continuously to achieve a simple and accurate recording of a patient's vital signs for up to 7 days. It is controlled and operated by Rooti Rx App, an iOS application developed by Rooti Labs Ltd.

TGA Public Summary