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510(k) Data Aggregation

    K Number
    K061912
    Device Name
    FUSION
    Manufacturer
    BURKE, INC.
    Date Cleared
    2006-08-01

    (26 days)

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

    BURKE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Motorized five-wheeled battery powered scooter intended for medical purposes by disabled persons and other non-medical purposes.
    Device Description
    The Fusion is an indoor/outdoor scooter that is battery operated. Fusic standard technology seating, thumb operated throttle, digital controller rarger, motor, brake, transaxle, frame material and till we have used for years on our - - Saver units. The Fusion frame separates for transport and has removable batteries anc تحتوب Accessories include a front light and a basket.
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    K Number
    K023961
    Device Name
    SCOUT BOSS
    Manufacturer
    BURKE, INC.
    Date Cleared
    2002-12-24

    (25 days)

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

    BURKE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals.
    Device Description
    Not Found
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    K Number
    K982158
    Device Name
    SCOUT
    Manufacturer
    BURKE, INC.
    Date Cleared
    1998-08-31

    (73 days)

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

    BURKE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Motorized battery powered wheelchair for mobility purposes by disabled persons.
    Device Description
    Not Found
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    K Number
    K965123
    Device Name
    PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
    Manufacturer
    BURKE, INC.
    Date Cleared
    1997-07-17

    (244 days)

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

    BURKE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Motorized three-wheeled and four-wheeled battery powered scooters are intended for medical purposes by disabled persons and other non-medical purposes.
    Device Description
    Not Found
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