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510(k) Data Aggregation

    K Number
    K113488
    Device Name
    JAZZY ELITE 6
    Manufacturer
    PRIDE MOBILITY PRODUCT CORPORRATION
    Date Cleared
    2012-04-18

    (147 days)

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

    PRIDE MOBILITY PRODUCT CORPORRATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
    Device Description
    The Jazzy Elite 6 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Jazzy Elite 6 is equipped with electronic regenerative disc brakes, 3A off-board battery charger, removable 12 volt batteries, drive wheels, and front and rear caster wheels. The Jazzy Elite 6 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
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    K Number
    K112815
    Device Name
    QUANTUM BARIATRIC 451
    Manufacturer
    PRIDE MOBILITY PRODUCT CORPORRATION
    Date Cleared
    2012-02-29

    (155 days)

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

    PRIDE MOBILITY PRODUCT CORPORRATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Pride Mobility Products Corporation Quantum Bariatric 451 is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
    Device Description
    The Quantum Bariatric 451 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Quantum Bariatric 451 is equipped with electronic regenerative disc brakes, 8A off-board battery charger, removable 12 volt batteries, front anti-tip wheels, and rear caster wheels. The Quantum Bariatric 451 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
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