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510(k) Data Aggregation

    K Number
    K101109
    Device Name
    VIVATRAK
    Manufacturer
    WIRELESS MEDCARE, LLC
    Date Cleared
    2010-07-15

    (86 days)

    Product Code
    KMI
    Regulation Number
    880.2400
    Why did this record match?
    Applicant Name (Manufacturer) :

    WIRELESS MEDCARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VivaTRAK™ system monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system providers information related to patient status and care delivered. The VivaTRAK™ system is not intended to provide automated treatment decisions or used as a substitute for professional healthcare judgment. The VivaTRAK™ system is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.
    Device Description
    The VivaTRAK 110 system is used for monitoring in-bed patient activity and care delivery. The system monitors in-bed patient activity with the BedSense sensor, an under-the-mattress activity sensing pad, processing and wireless transmission of activity data with the ActivSense "M Bed Computer, and providing pager, email, phone and display notifications and care reports to the nursing staff, and then verifying using RFID readers that care was actually delivered with the VivaTRAKTM application. Care reports consisting of a notification, a RFID scan and bed activity are stored in a database and form the basis for reports used to improve quality of care and work flows at the facility.
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