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510(k) Data Aggregation

    K Number
    K140938
    Device Name
    OSTOM-I ALERT
    Manufacturer
    11 HEALTH AND TECHNOLOGIES LLC
    Date Cleared
    2014-10-10

    (182 days)

    Product Code
    EXB, EZQ, EZS
    Regulation Number
    876.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    11 HEALTH AND TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient. The OSTOM-i™ Alert is indicated for all patient populations. The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment. The OSTOM-i™ Alert is indicated for all patient populations.
    Device Description
    The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn the health care provider when their patients' bags are close to being full, or to the patient in the post-hospital setting. The flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag. This information is relayed to the tablet generating an additional report on bag status versus the visual one now available.
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