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510(k) Data Aggregation

    K Number
    K020536
    Device Name
    GAZELLE WHEELCHAIR
    Manufacturer
    ALUM CREEK WHEELCHAIR CO., INC.
    Date Cleared
    2002-03-15

    (24 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALUM CREEK WHEELCHAIR CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gazelle Wheelchair is a lightweight manual wheelchair designed for individuals who need assistance in transportation. It provides mobility based upon an individual user's needs and capabilities.
    Device Description
    Not Found
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