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510(k) Data Aggregation

    K Number
    K954671
    Device Name
    THE FREEDOM BED
    Manufacturer
    PROBED MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-04-01

    (174 days)

    Product Code
    IKZ
    Regulation Number
    890.5225
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROBED MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Freedom Bed PAR 3 is used to automatically reposition immobilized persons from side to side either manually or on a programmed schedule aide in the prevention of decubitus ulcers in bed ridden patients.
    Device Description
    The device is a programmable, automatically or manually operated repositioning bed designed for the prevention of decubitus ulcers. The device consists of 3 separate platen sections joined together with flexible hinges. The center section rotates left and right to a maximum of 30 degrees on each side, while the appropriate outer section rotates up to support and contain the sleeper. This provides a surface to transfer weight onto, as well as prevents the user from sliding or falling out of bed. The microprocessor based controller provides adjustment of time, angle and speed, as well as a choice of manual operation, automatic operation, or patient control. This allows most users to achieve independence from night time attendants and higher quality and duration of sleep. The bed has received UL 544, CSA, and FCC approvals.
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