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510(k) Data Aggregation

    K Number
    K160139
    Device Name
    Luggie Chair
    Manufacturer
    FREERIDER CORPORATION
    Date Cleared
    2017-03-20

    (424 days)

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

    FREERIDER CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
    Device Description
    The FR-W04 (Luggie Chair) is a battery-powered, four-wheeled electric wheelchair intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-W04 (Luggie Chair) is meant to be used by a single rider weighing up to 360 pounds. The wheelchair is rear-wheel drive and has electric, regenerative electromechanical brakes. The steering and user controls are provided on the armrest for ease of use by the rider. Steering is controlled simply by turning the top controller in the desired direction. There is one lever, and speed knobs on the top controller to control movement speed of the wheel chair. The specification of control method is the same as the predicate device, Freerider FR168-W Power Chair (K033370). The FR-W04 (Luggie Chair) has a controller and one lithium battery. There is also an off-board battery charger, which has also been previously cleared. It has an adjustable seat that has several height adjustments. The specification of battery charger and adjustable seat is the same as the predicate device, Freerider Luggie Super FR-L05 (K151944).
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    K Number
    K151944
    Device Name
    Luggie Super
    Manufacturer
    Freerider Corporation
    Date Cleared
    2015-09-10

    (58 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Freerider Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FR-L05 (Luggie Super) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
    Device Description
    The FR-L05 (Luggie Super) is a battery-powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-L05 (Luggie Super) is meant to be used by a single rider weighing up to 360 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that has several height adjustments. The steering and user controls are provided on the steering tiller/handlebars for ease of use by the rider. Steering is controlled simply by turning the handlebars in the desired direction. There are two thumb levers, and speed knobs on the tiller console to control movement speed of the scooter. The FR-L05 (Luggie Super) has a controller and 1 lithium battery. There is also an off-board battery charger.
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