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510(k) Data Aggregation

    K Number
    K233096
    Device Name
    PRESSUREALERT® Pressure Monitoring System
    Manufacturer
    Walgreen Health Solutions, LLC
    Date Cleared
    2024-06-21

    (269 days)

    Product Code
    SBO
    Regulation Number
    880.2400
    Why did this record match?
    Product Code :

    SBO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRESSUREALERT® Pressure Monitoring System monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to medividualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the healthcare providers. The device is in medical, nursing, and longterm care facilities including independent living, assisted living, and rehabilitation facilities.
    Device Description
    The PRESSUREALERT® Pressure Monitoring System is composed of a wireless pressure sensing dressing assembly as part of a system supported by the PRESSUREALERT® Management Software for providing a warning to the healthcare provider that soft tissue pressure has exceeded a predetermined level that, over a period of time, would necessitate that the patient should be moved to prevent or at least reduce the risk of soft tissue damage. The PRESSUREALERT® Pressure Monitoring System functions as a pressure monitoring system with the primary function to monitor a patient that is laying down on their back or otherwise in a position that may result in the patient's weight applying pressure to an area of the patient's body that is susceptible to pressure ulcers/injuries, such as soft tissue overlying a bony prominence. The dressing assembly, with the enclosed pressure sensor, is applied on the patient's body that is susceptible to damage from soft tissue pressure. The identified areas are referred to as "at-risk" in the instructional documentation and intended use and include up to eleven (11) sites defined as the upper spine, head-skull, hip (right or left), Ischia (right or left), heels and elbows (right or left), and sacrum. The material components of the PRESSUREALERT® Pressure Monitoring System, and described in detail in the Device Description section, includes: - i. PRESSUREALERT® Segmented Oval Dressing - ii. PRESSUREALERT® Round Dressing - iii. PRESSUREALERT® Sacral Dressing - iv. PRESSUREALERT® Oval Sensor - v. PRESSUREALERT® Round Sensor
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