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510(k) Data Aggregation

    K Number
    K220698
    Device Name
    Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
    Manufacturer
    Panthera AB
    Date Cleared
    2023-02-16

    (344 days)

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

    Panthera 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 of a spoke and hub design and made of chrome-molly steel to construct the chassis (frame and back rest), except for the X model which uses carbon fiber reinforced composite (CFRC) instead of chrome-molly steel. All Panthera mechanical wheelchairs have rubber tires, while the casters are of a semi-solid polymer-based design. The seat cushions and backs 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 weight carrying capacities, adjustability features, wheels, accessories and hardware options.
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