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510(k) Data Aggregation

    K Number
    K190682
    Device Name
    Explorer Mini
    Manufacturer
    Permobil AB
    Date Cleared
    2020-02-27

    (346 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Permobil AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.
    Device Description
    The Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column. The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick. The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving. The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles. The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module. When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake.
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    K Number
    K191874
    Device Name
    F5 Corpus VS
    Manufacturer
    Permobil AB
    Date Cleared
    2019-10-25

    (105 days)

    Product Code
    IPL, ITI
    Regulation Number
    890.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Permobil AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The F5 Corpus VS powered wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
    Device Description
    F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's 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 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 to stop by letting go of the joystick. F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues. The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.
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    K Number
    K143180
    Device Name
    F3
    Manufacturer
    PERMOBIL AB
    Date Cleared
    2015-03-27

    (143 days)

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

    PERMOBIL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the F3 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair. The intended use of the F3 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
    F3 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F3 is powered by two 12VDC 60Ah or tow 12VDC 73Ah. Group M34 batteries or Group M24. approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive wheels with drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's 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 joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.
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    K Number
    K143014
    Device Name
    F5
    Manufacturer
    PERMOBIL AB
    Date Cleared
    2015-03-25

    (156 days)

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

    PERMOBIL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the F5 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair. The intended use of the F5 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
    F5 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 is powered by two 12VDC 73Ah. Group M24. approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's 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 joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.
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    K Number
    K123290
    Device Name
    M300 & M400
    Manufacturer
    PERMOBIL AB
    Date Cleared
    2013-04-17

    (177 days)

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

    PERMOBIL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the M300 & M400 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
    M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 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 center drive wheels with drive units (motor, gear, brake), batteries and front and rear 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
    K103477
    Device Name
    PERMOBIL M300 / M400
    Manufacturer
    PERMOBIL AB
    Date Cleared
    2011-03-03

    (97 days)

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

    PERMOBIL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the M300 & M400 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
    M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 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 center drive wheels with drive units (motor, gear, brake), batteries and front and rear 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
    K081964
    Device Name
    K450 POWERED WHEELCHAIR
    Manufacturer
    PERMOBIL AB
    Date Cleared
    2008-07-29

    (19 days)

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

    PERMOBIL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the K450 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 K450 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
    K450 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair R-net PM120 amp controller. The user interface is a joystick. The K450 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 26,9 km (16,7 miles), depending on use and the terrain the chair is driven on. The chair frame is a 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
    K071650
    Device Name
    C350 POWERED WHEELCHAIR
    Manufacturer
    PERMOBIL AB
    Date Cleared
    2007-09-12

    (86 days)

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

    PERMOBIL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the C350 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
    C350 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair VR-2 70 amp controller. The user interface is a joystick. The C350 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 22 km (13.75 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 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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