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510(k) Data Aggregation

    K Number
    K973418
    Device Name
    UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
    Date Cleared
    1997-10-09

    (29 days)

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

    ASSEMBLY REQUIRED DIST., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.
    Device Description
    Wheelchair to be a manual transport device, with 8" fron swivel casters on the front, and 24" mag style wheels on the rear. Wheelchair will be foldable for storage, will be chrom- plate Finnish. Armrests will be padded or plastic and wil have padded embossed upholstery for user comfort. Wheelchair will be equipped with wheel locks to prevent rolling while transferring patient. Push handles will be of a non-slip vinyl material. Standard color available will be dark blue. Chairs to have rear extensions to prevent tip-over. Wheelchairs to be available in models with swing away footrests or elevating legrests as shown in pictures.
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