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510(k) Data Aggregation

    K Number
    K965207
    Device Name
    RID-DECUBE II
    Manufacturer
    SKIN CARE MANAGEMENT, INC.
    Date Cleared
    1997-08-21

    (237 days)

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

    SKIN CARE MANAGEMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RID-Decube II Alternating Pressure Mattress System is intended for medical purposes to be used to prevent and treat decubitus ulcers.
    Device Description
    The RID-decube II is an alternating pressure air flotation mattress intended for medical purposes with multiple air cells that can be filled and emptied in an alternating pattern by associated control units to provide regular, frequent and automatic changes in the distribution of body pressure.
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