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510(k) Data Aggregation

    K Number
    K190550
    Device Name
    IKON 40 Manual Wheelchair
    Manufacturer
    Broda Seating (Broda LP)
    Date Cleared
    2019-07-01

    (118 days)

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

    Broda Seating (Broda LP)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The standard IKON 40 is a manual wheelchair device that is intended to be used to provide mobility to persons ages 12 and over (adolescents and adults) with a weight capacity of 300 lbs. The device is to be used as a means of mobility for persons limited to a sitting position.
    Device Description
    The IKON 40 is a foldable, ultra-lightweight and fully adjustable manual wheelchair.
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