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510(k) Data Aggregation

    K Number
    K142770
    Device Name
    Powered Wheelchair
    Manufacturer
    AAT ALBER ANTRIEBSTECHNIK GMBH
    Date Cleared
    2015-06-09

    (257 days)

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

    AAT ALBER ANTRIEBSTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SOLO+, SOLO and SERVO turn a manually propelled wheelchair into a powered wheelchair. They are intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.
    Device Description
    The subject devices SOLO, SOLO+ and SERVO are power-wheelchair-conversion-kits that add powered propulsion to a manual wheelchair, thereby, turning a manual wheelchair into a powered wheelchair. They consist of two powered wheels (each incorporating an electrical motor) a control unit with its bracket and a battery pack. A battery charger and a bag for the battery pack are included in the delivery as well. The powered wheels substitute the conventional manual wheels from selected wheelchairs. The battery-pack and the controller-unit can easily be attached to the wheelchair. Speed, acceleration and deceleration are microprocessor-controlled. A preselection of the maximum speed can be done with buttons on the control unit. The wheelchair will accelerate or drive with steady speed when the joystick (SOLO and SOLO+) or the hand-rims (SERVO) are pushed into the travel-direction. The motors will steadily reduce the driving force until the wheelchair stops if no driving-signal (deflection of the joystick or the rim) is provided. The safety-brakes lock automatically when the wheelchair stopped (SOLO, SOLO+). The manual parking brakes can also be used to prevent unintended movement. After ten minutes of non-use the device turns off automatically. The powered wheels can be disengaged if the user wants to drive with manual propulsion, only.
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    K Number
    K130864
    Device Name
    C-MAX+ (PLUS)
    Manufacturer
    AAT ALBER ANTRIEBSTECHNIK GMBH
    Date Cleared
    2014-02-06

    (315 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAT ALBER ANTRIEBSTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powered patient stairway chair lift; Intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway. The product c-max+ (plus) offers motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. to move from one level to another.
    Device Description
    With the c-max+ people can transport a patient safely and comfortably up- and downstairs. The maximum load is 300kg. The device is safe due to automatic brakes and a rigid frame. It is suitable for almost all kinds of stairs, winding stairs excluded. The climbing system requires low maintenance and care. On stairs as well as on level ground C-Max+ proves its versatility. Removable arm rests make easy transferring from one chair to another possible. Due to its compact dimensions and foldable foot rest, the C-Max+ is easy to manoeuvre even on very narrow stair cases. For small, compact apartments with narrow doorways, the C-Max+ represents the ideal solution. At the heart of the matter lies the patented climbing mechanism, which virtually climbs stairs all by itself. It also makes the C-Max+ particularly versatile and safe. Once the patient has seated and fastened the seat belt, the care attendant needs little physical power to handle the C-Max+. The C-Max+ is individually adjustable. Wheels make the transport on the floor easy. The battery-powered stair-climbing mechanism is usercontrolled with adjustable speed and climbing-direction. The attendant can also choose a single-step-mode alternatively to fluent climbing. A safety-brake ensures safe stops during the stair-climbing.
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    K Number
    K103122
    Device Name
    C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG
    Manufacturer
    AAT ALBER ANTRIEBSTECHNIK GMBH
    Date Cleared
    2010-12-30

    (70 days)

    Product Code
    ILK, ING
    Regulation Number
    890.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    AAT ALBER ANTRIEBSTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The products c-max and s-max offer motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.to move from one level to another with or without manual wheelchair adaption.
    Device Description
    The products c-max and s-max offer motorized stair-climbing support for disabled seated persons to move from one level to another with or without manual wheelchair adaption.
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