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510(k) Data Aggregation

    K Number
    K212954
    Device Name
    G-Tech Wireless Patch System (WPS)
    Manufacturer
    G-Tech Medical
    Date Cleared
    2022-01-10

    (116 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Applicant Name (Manufacturer) :

    G-Tech Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
    Device Description
    The G-Tech System is a non-invasive wireless gastrointestinal monitoring system for use by the physician or staff in the hospital setting, clinic, or physician's office. The device is intended for use while the patient is under direct supervision (e.g., in hospital or clinic) as well as after discharge to home or to intermediate setting. The device is for prescription use only. The device consists of the G-Tech Patch, the G-Tech Patch Monitor, an iOS application, a secure cloud storage server and computer-based data analysis algorithms. The G-Tech Patch is a single use, wearable electrode patch that reads the electrical signals of the gastrointestinal tract from the abdominal skin surface. The Patch transmits the acquired electrical signals via Bluetooth to the G-Tech Patch Monitor. The G-Tech Patch Monitor receives the raw data, encrypts it, and periodically uploads it to a secure cloud server. Additionally, the Patch Monitor has a patient interface to allow the patient to manual enter events such as meals, bowel movements, pain or the taking of medications. Data analysis algorithms process the uploaded data to measure and report myoelectrical activity for the stomach and intestines. These measurements are made available to physicians for aid in clinical evaluation of their patient.
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