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510(k) Data Aggregation

    K Number
    K163694
    Device Name
    Rooti Rx ECG Event Recorder, Rooti Link APP Software
    Manufacturer
    Date Cleared
    2017-11-07

    (314 days)

    Product Code
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rooti Labs Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time. - The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.
    Device Description
    Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, patch, charging dock and Rooti Link. When operating Rooti Rx System, medical professionals should use disposable, off the shelf, standard ECG electrodes which are not claimed in the system.
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