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510(k) Data Aggregation

    K Number
    K240843
    Device Name
    GENESIS (MS-P02-GEN)
    Manufacturer
    Climbing Steps Inc.
    Date Cleared
    2024-10-07

    (194 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs. The Stairlift is capable of moving adult, adolescent occupants (12 years and up) who are able to remain seated while secured by the safety belt. The Mobile Stairlift is for residential use with proper training. This device can also be used routinely in a hospital environment or as a tool for all types of medical personnel. The target patient population are disabled seated persons i.e. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.
    Device Description
    The Mobile Stairlift is a manual transport device which transports the ride in a seated upright position up or down a flight of stairs.
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    K Number
    K222818
    Device Name
    Xpedition ™ Powered Stair Chair (625700000000)
    Manufacturer
    Stryker Medical
    Date Cleared
    2023-01-24

    (127 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Xpedition transports a patient with a mobility-limiting medical condition or injury, who is physically able to maintain a seated position while restrained, up or down a set of stairs. Xpedition is intended for use in residential and commercial environments, including pre-hospital environments, emergency, and non-emergency applications. All operators, including healthcare professionals such as emergency medical service personnel and medical first responders, must be trained by a qualified trainer before product use.
    Device Description
    The Stryker Xpedition™ Powered Stair Chair is a seated patient transport device with handles and a powered belt and track system. The chair is designed to support and transport a maximum weight of 500 1b (227kg) up and down stairs. The chair is intended for patients who weigh 50 lb (23 kg) or more and can remain seated in the chair while secured by patient restraint straps. Handles at the head and foot ends allow operators to control the chair during powered or manual ascent or descent on stairs. Operators can push and maneuver the chair over various types of terrain expected in commercial and residential environments, as well as lift patients over obstacles. The chair has a removable patient containment system with attachment points for the chest and waist to secure a patient during transport. A fold-out footrest can be deployed for secure feet placement. A removable, rechargeable battery powers electrical functions including the motorized drive system for traversing stairs, speed selection, direction, ground lighting activation, battery capacity feedback, drive activation buttons, and LED visual feedback networks. User interfaces at the back of the chair and the top handle allow for drive system control. The chair has several mechanical activations including wheel locks to prevent unintended motion on ground, a latch to fold or unfold the chair, a track deployment mechanism to deploy the stair driving track system, and top and bottom handle length adjustment activations. Options include the footrest and head end flip-up carry handles.
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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?
    Product Code :

    ILK

    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
    K121560
    Device Name
    LEVANT, HOMEGLIDE
    Manufacturer
    THYSSENKRUPP ACCESSIBILITY B.V.
    Date Cleared
    2012-11-01

    (156 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ThyssenKrupp Accessibility's Battery Operated Stair Lift LEVANT is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down straight stairs, indoors and outdoors.
    Device Description
    Levant/ HomeGlide is a stair lift for transport of one person up and down straight stairs. The system consist of a drive unit, a foldable footrest and an aluminum rail that is fixed on the stairs. The system can be fixed on either sides of the stairs. It is available standard with a manual swivel for easy getting on and off the seat. It comes with a padded seat. A hinged rail, a heavy duty drive and a intermediate park position are available as options. The Comfort Option provides a premium positioned chair lift with extra options: straight or curved armrests, luxurious seat, fabric- vinyl- or leather upholstery, adjustable seat height, and a powered swivel. The Outdoor Option provides a stair lift for outdoor use in both cold and warm climates. The Outdoor option is created by adding a waterproof control, a waterproof cover, coated electronics, coated switches, waterproof charging contacts and a step up transformer.
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    K Number
    K121561
    Device Name
    FLOW2, SWING
    Manufacturer
    THYSSENKRUPP ACCESSIBILITY B.V.
    Date Cleared
    2012-10-26

    (150 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ThyssenKrupp Accessibility's Battery Operated Stair Lift FLOW2 is intended to mechanically transport one mobility impaired person in a fold-down seat, up and down curved stairs, indoors.
    Device Description
    Flow2 mono rail chairlift brings one person safely and comfortably up and down the stairs. In the meantime one saves ones energy for long outdoor walks, playing with the children or the daily tasks in house. Flow2 is capable to swivel during the ride up and down the stairs. This unique and patented feature makes that Flow2 chairlift fits most staircases, straight, around corners and even spiral. The angle of the staircase can vary from -70 degrees up to 70 degrees. The footrest is mounted directly to the chair. This provides a comfortable and ergonomic seating position of the user with less knee flexion. Flow2 is easy to use by a simple and light folding operation and the intuitive to use joystick control. Features such as anti squeeze, curved armrest and safety belt provide additional safety for the user and other inhabitants of the home. The design can be adapted to the home decor by the application of a variety of different seat fabrics and colors. Flow2 is the chairlift on the market which combines the best of 2 worlds; capable to fit on the smallest stairs while transporting the user in the most comfortable and safe way.
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    K Number
    K113308
    Device Name
    BRUNO ELAN STAIRWAY ELEVATOR
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC.
    Date Cleared
    2012-02-01

    (84 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bruno Élan Stairway Elevator System, Model SRE-3000, is a single user transport system, also commonly known as a stairway chairlift, or stairlift. It is a motorized device intended to assist transfers of a mobility impaired person up or down flights of stairs.
    Device Description
    The Bruno Élan Stairway Elevator System, Model SRE-3000, is a single user transport system, also commonly known as a stairway chairlift, or stairlift. It is a motorized device intended to assist transfers of a mobility impaired person up or down flights of stairs.
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    K Number
    K111858
    Device Name
    LIFTKAR PT
    Manufacturer
    SANO TRANSPORTGERAETE GMBH
    Date Cleared
    2011-11-04

    (127 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIFTKAR PT™-S Is a method of transporting disabled persons, up and downstairs while seated on the stairclimber, and not in a wheelchair. This is done with a lifting mechanism. It is a battery on the bailed in the been and on a certified attendant and can be used on any stairs indoors or outside.
    Device Description
    The LIFTKAR PT™ S is an attendant operated, battery powered lifting device that transports a disabled person in an integrated chair up or down stairs, not in a wheelchair. The LIFTKAR PT-S is designed for indoor and outdoor use allowing mobility for the person needing assistance.
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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?
    Product Code :

    ILK

    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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    K Number
    K093946
    Device Name
    HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
    Manufacturer
    HOVEROUND CORP.
    Date Cleared
    2010-03-22

    (89 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use is to assist transfer of an individual up or down a straight, residential, indoor staircase while in a seated position.
    Device Description
    Not Found
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    K Number
    K091858
    Device Name
    PINNACLE STAIR WAY LIFT
    Manufacturer
    SUMMIT HARMAR, LLC
    Date Cleared
    2009-07-01

    (8 days)

    Product Code
    ILK
    Regulation Number
    890.5150
    Why did this record match?
    Product Code :

    ILK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pinnacle Stair Way Lift is intended to assist transfers of patients or mobility impaired persons up and down flights of stairs.
    Device Description
    The Harmar Summit, LLC Pinnacle Stair Way Lift is a battery powered patient transport. It's intended function and use is to assist transfers of patients or mobility impaired persons up and down flights of stairs. It is intended for indoor use only. The system is designed to carry a single patient, up a single flight of stairs while seated, at angle of between 27-45 degrees. Maximum travel distance is 75' at the maximum patient weight is 350 lbs. Maximum travel speed at full rated load is 20' per minute.
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