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510(k) Data Aggregation

    K Number
    K200135
    Device Name
    RGK Daily Range Wheelchairs
    Date Cleared
    2020-09-10

    (233 days)

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

    RGK Wheelchairs, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RGK Daily Range Wheelchairs are mechanical wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.
    Device Description
    The RGK Daily Range Wheelchairs are mechanical wheelchairs that include four wheels, an aluminum or titanium frame, and a black nylon upholstery that is flame resistant. Each wheelchair includes multiple components such as wheels, castors, sideguards, footplates and wheel locks.
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