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510(k) Data Aggregation

    K Number
    K080385
    Device Name
    CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
    Manufacturer
    E1 ENT., INC.
    Date Cleared
    2008-05-13

    (90 days)

    Product Code
    ITI, 89I
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    E1 ENT., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide cnhanced mobility to physically challenged persons limited to a sitting position.
    Device Description
    The Tuffcare Cruiser P5500 Challenger powered wheelchair is an indoor / outdoor powered wheelchair that is battery operated. The product has a metal frame with four wheels and front anti tipping devices, adjustable seat with armrests, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for thansport and is provided with a battery charger.
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