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510(k) Data Aggregation

    K Number
    K974070
    Device Name
    PHYSIO/1000
    Manufacturer
    PHYSIO DESIGNS, INC.
    Date Cleared
    1998-01-06

    (70 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHYSIO DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.
    Device Description
    Physio / 1000 Alternating Pressure Mattress System
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