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510(k) Data Aggregation

    K Number
    K182840
    Device Name
    Element Pediatric Wheelchair
    Manufacturer
    Date Cleared
    2019-04-29

    (202 days)

    Product Code
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Leggero llc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Element pediatric wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
    Device Description
    The Element Pediatric Wheelchair is designed for children who are limited to a seated position and require mobility and positioning assistance. It is intended for individuals less than 21 years old, who weigh less than 185 pounds. The Element Pediatric Wheelchair consists of a frame and wheels (part number 3101-0000). The frame is powder-coated aluminum and the non-inflatable wheels are polyurethane plastic. The seat back, seat bottom, restraints and armrests are covered in flame retardant nylon fabric. The footrests are powder-coated aluminum. The seat back, seat bottom, armrests, footrests, and restraints are specified by a professional wheelchair fitter. Parameters such as seat width (18-28") and depth (10-22") are changeable over the course of use. This adds adjustability to the wheelchair to meet the needs of growth, postural changes, and level of disability. Parameters adjustable by manufacturer or distributor include: seat width, seat depth, seat to floor height, wheel size, wheel base distance. Parameters adjustable by user include: back cane height, tilt of chair, foot rest height, and seat back angle (recline). The Element has a "Transit Option" that is compliant with RESNA WC-19. The Element is foldable for storage or transport. The Element was designed for firm and smooth surfaces, both indoors and outdoors. It is intended for surfaces with less than 5° slope. A back cane hand grip is provided for an attendant to push. Principle of Operation: The Leggero Element Pediatric Wheelchair provides a stable seat and wheel chassis designed to provide mobility to persons restricted to a sitting position.
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