The Rooti Rx app is made for medical professionals to be used in conjunction with the Rooti Rx System ECG Event Recorder. Its sole purpose is to set up the FDA registered device. The Rooti Rx app does NOT analyze a patient’s medical condition or display any analysis results or medical advice.
When using the app, medical professionals are required to login to their registered account to set up the Rooti Rx System ECG Event Recorder. The Rooti Rx app does not work without login authorization.
The Rooti Rx System ECG Event Recorder is not available to everyone. It is only distributed to registered medical professionals for prescribed patient use. Prescribed patients will need to seek a doctor’s advice further before making any medical decisions.
FDA 510(k) numbers: K163694
EC Certificate Full Quality Assurance System FI16/07021
TFDA: 005772
ARTG Identifier: 300643
When using the app, medical professionals are required to login to their registered account to set up the Rooti Rx System ECG Event Recorder. The Rooti Rx app does not work without login authorization.
The Rooti Rx System ECG Event Recorder is not available to everyone. It is only distributed to registered medical professionals for prescribed patient use. Prescribed patients will need to seek a doctor’s advice further before making any medical decisions.
FDA 510(k) numbers: K163694
EC Certificate Full Quality Assurance System FI16/07021
TFDA: 005772
ARTG Identifier: 300643
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