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510(k) Data Aggregation

    K Number
    K083231
    Device Name
    PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT
    Manufacturer
    PANTHERA PRODUCTION AB
    Date Cleared
    2009-01-26

    (84 days)

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

    PANTHERA PRODUCTION AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair
    Device Description
    Panthera mechanical wheelchairs are manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time These wheelchairs are made available by Panthera Production AB in five (5) different top-level models, with each model designed for a specific end-user application The five different models of chairs are the S2, U2, Bambino, Micro, and BT. There are no basic differences in the general construction of each model wheelchair frame, or the materials and components used to make them The Chassis are made form chrome-molly steel, while their Pushrims and Footrests are made from a titanium alloy Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design The seat cushion and back are made from flame retardant polyurethane coated polyester fabric, over a foam core The primary differences in the models of wheelchairs are in their dimensions, gross weights, weight carrying capacities, adjustability features, wheels, accessories and hardware options
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