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510(k) Data Aggregation

    K Number
    K041219
    Device Name
    ELECTRO
    Manufacturer
    PERMOBIL A.B.
    Date Cleared
    2004-08-04

    (86 days)

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

    PERMOBIL A.B.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ELECTRO powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. The intended use of the Electro series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
    Device Description
    Electro Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VSI 70 amp controller. The user interface is a joystick. The Electro is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25 km (16 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two front drive wheels with drive units (motor, gear, brake), batteries and back pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
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    K Number
    K032765
    Device Name
    STREET
    Manufacturer
    PERMOBIL A.B.
    Date Cleared
    2004-01-30

    (147 days)

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

    PERMOBIL A.B.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the STREET powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
    Device Description
    Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
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    K Number
    K993406
    Device Name
    TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0
    Manufacturer
    PERMOBIL A.B.
    Date Cleared
    2000-12-18

    (437 days)

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

    PERMOBIL A.B.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of TRAX is to provide indoor and outdoor mobility to persons restricted to a sitting position. Powered wheelchair, battery-operated device with wheels that is intended for medical purposes to provide indoor and outdoor mobility to persons restricted to a sitting position. Class II. The indoor use is depending of available space.
    Device Description
    The Permobil powered wheelchair TRAX is rear wheel driven, battery powered, motor driven and is controlled by the Permobil wheelchair controller SAFEGATE. The user interface is a joystick manufactured by Sakai for proportional control of the speed and the steering. The wheelchair is powered by two 12V 97 Ah gel batteries. Theoretical driving range on the fully charged batteries is 30 - 50 km depending of the terrain the chair is driven on. The wheelchair consists of the following basic sub-sections: - · Base with two direct-drive units with integrated parking brakes, two 10"x3" rear wheels, suspension with stabilizer and two 12V 97Ah batteries. - Extendable and pivoted front, length adjustable 0-200 mm (0-8"), teleflex . wire steering, suspension and two 8"x2,5" front wheels. - - SAFEGATE TRAX Power electronics. . - · Seating system. The base is of welded steel construction with laser cut sheet details. The direct-drive units consist of two 12V DC permanent magnet motors with gears and integrated parking brakes.
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    K Number
    K991658
    Device Name
    PERMOBIL POWERED WHEELCHAIR 1280
    Manufacturer
    PERMOBIL A.B.
    Date Cleared
    1999-10-08

    (147 days)

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

    PERMOBIL A.B.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Permobil powered wheelchair 1280 is to provide indoor and outdoor mobility to persons restricted to a sitting position.
    Device Description
    The Permobil powered wheelchair 1280 is front wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact powered wheelchair controller Pilot +. The joystick is integrated in the controller. The wheelchair is powered by two 12V 73 Ah batteries. Theoretical driving range on the fully charged batteries is 35 km. The wheelchair consists of two basic sub-sections. These are the base with motor controller and the body supporting system. In this submission, only the design changes made to base is included. The base is of welded steel construction and includes the base frame, front drive wheels with drive unit (motor/gear/brakes), batteries and pivoting rear casters. The motor controller is mounted to the left or right armrest, depending on user needs. The motor controller, including the joystick, is housed in a pressure die cast aluminum enclosure.
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    K Number
    K960951
    Device Name
    PERMOBIL CHAIRMAN L/CS 8
    Manufacturer
    PERMOBIL A.B.
    Date Cleared
    1997-04-30

    (415 days)

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

    PERMOBIL A.B.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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