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510(k) Data Aggregation

    K Number
    DEN140033
    Device Name
    Companion
    Manufacturer
    LGCH, INC
    Date Cleared
    2017-02-16

    (829 days)

    Product Code
    POS
    Regulation Number
    882.1580
    Why did this record match?
    Applicant Name (Manufacturer) :

    LGCH, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
    Device Description
    The Brain Sentinel Monitoring and Alerting System is a sEMG-based system for identifying sEMG activity that may be associated with generalized tonic-clonic seizures (GTCS). The device has two main components: the sEMG monitor and the base station. The sEMG monitor is worn on the patient's upper arm and monitors EMG activity in the arm via cutaneous electrodes connected to the sEMG monitor. Upon identification of sEMG activity, the monitor communicates wirelessly to the base station, which alerts a healthcare provider or caregiver in one or more ways (e.g., audible alarm, text message, e-mail, etc.).
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