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510(k) Data Aggregation

    K Number
    K213233
    Device Name
    EZYPRO ECG Recorder (Model: UG02)
    Date Cleared
    2022-06-23

    (266 days)

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

    Sigknow Biomedical Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac thythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recorded ECG data can be transferred in an available file on PC via the USB connection. During wearing, EZYPRO ECG Recorder (Model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation. UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
    Device Description
    EZYPRO ECG Recorder (Model: UG02) can record cardiac rhythm up to 14 days. Wearing duration is adjustable based on different needs of the physicians. The recorder is lightweight, wire free, and easy to carry around; Will not interfere patient's daily routine or any activities. Patient's symptomatic episodes can be marked by proactive pressing the blue button on the recorder; Physicians could later look back at the data and use it in the diagnosis. EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis.
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