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510(k) Data Aggregation

    K Number
    K223533
    Device Name
    Little Wave Arc; Little Wave Flip
    Manufacturer
    Ki Mobility LLC
    Date Cleared
    2023-08-31

    (281 days)

    Product Code
    LBE
    Regulation Number
    890.3850
    Why did this record match?
    Product Code :

    LBE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ki Mobility Little Wave Arc and Little Wave Flip manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.
    Device Description
    The Ki Mobility Little Wave Arc is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the seated pressure distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as eating, breathing and social interaction. The Little Wave Arc offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant. The Ki Mobility Little Wave Flip is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as ocial interaction. The Little Wave Flip offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant.
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    K Number
    K130644
    Device Name
    PEDIATRIC FOLDING WHEELCHAIR
    Manufacturer
    COLUMBIA MEDICAL MFG, LLC
    Date Cleared
    2013-10-16

    (219 days)

    Product Code
    LBE
    Regulation Number
    890.3850
    Why did this record match?
    Product Code :

    LBE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Columbia Medical Pediatric Folding Wheelchair is a manually propelled wheelchair designed to provide mobility aid for children and adolescents who have limited or no ability to ambulate and require a device to aid in seated mobility in the home and community.
    Device Description
    This pediatric wheelchair, also commonly referred to as an adaptive stroller, is constructed of the same typical components of most manual wheelchairs. The frame consists of powder coated round tubular 6061 T6 aluminum which is 1" in diameter, and is welded and bolted. The device comes standard with 13.5" rear wheels and 6" steering front casters. The back and seating area is made of a fabric material. The wheelchair is designed for everyday indoor and outdoor use in firm terrain. The wheelchair is designed to allow for adjustments of the orientation of the seat and back angles, using tools, to provide seating and back angles to support the skeletal and muscular characteristics of the individual for comfort, control and safety during sitting and mobility.
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