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510(k) Data Aggregation

    K Number
    K232210
    Device Name
    X-trodes System M
    Manufacturer
    X-Trodes
    Date Cleared
    2024-02-04

    (193 days)

    Product Code
    GWL, DPS, GXY, IKN
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    X-Trodes

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-trodes System M is intended for prescription use only in the home or healthcare facility to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes System M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.
    Device Description
    The X-trodes System M combines hardware, firmware, and software to acquire the following physiological signals: physiologic signal amplifier (EEG), electrooculography (EOG), surface electromyography (sEMG), electrocardiography (ECG), and accelerometer and gyroscope signals. It acquires physiological data through a data acquisition unit connected to electrode arrays patches, applied by a technician or patient to the patient. The data is recorded and transmitted to a cloud where it is converted to an EDF (European Data Format) format, suitable for analysis by third party software.
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