Rooti Rx ECG Event Recorder, Rooti Link APP Software
Rooti Labs Ltd.The Rooti Rx System is a wearable single-lead ECG recording device that allows patients to record ECG data at home or work. The data is stored on the device and later transmitted via Wi-Fi to medical professionals’ iOS devices for post-analysis, aiding clinicians in patient cardiac monitoring and diagnosis.
Intended Use
The intended use is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. It is indicated for use on general care patients who are 21 years or older and is not intended for critical care patients.
Technology
The Rooti Rx System consists of a wearable single-lead ECG recording device with patch, charging dock, and Rooti Link app. It uses standard disposable ECG electrodes for signal acquisition, stores ECG data locally, and transmits the data wirelessly via Wi-Fi to medical professionals' iOS devices.
Performance
Performance testing demonstrated substantial equivalence to the predicate device (Zephyr Technology BIOMODULE 3-M1), showing similar intended use, indications, and technological characteristics. Testing confirmed the device's ECG resolution, sampling rate, wireless transmission, and other technical parameters meet standards and do not raise new safety or efficacy issues.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/28/2016
10 months - 2
FDA Approval
11/7/2017
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