Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250576

    Validate with FDA (Live)

    Date Cleared
    2025-11-04

    (250 days)

    Product Code
    Regulation Number
    890.3850
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Flexx Junior manual wheelchair is intended to provide mobility to pediatrics limited to a seating position.

    Device Description

    The Flexx Junior is a pediatric manual wheelchair designed to provide mobility, comfort, and postural support for children with mobility limitations. Available in self-propelled (Model FLX-J00 with fixed backrest, Model FLX-J50 with foldable backrest) and transit configurations, it is primarily intended for indoor use with limited outdoor capability on smooth surfaces. The wheelchair offers both self-propulsion with 20" or 22" quick-release rear wheels and transit propulsion with 14" quick-release rear wheels. The device supports users weighing up to (165 lbs) 75 kg and is engineered for growth and incorporates adjustable features to accommodate growth.

    The Flexx Junior is constructed with a lightweight aluminum folding frame, ensuring durability and ease of transport. Its compact folded dimensions facilitate storage and transport in vehicles. The device offers adjustable seat width, seat depth, and backrest height to ensure a customized fit as the child grows. The wheelchair's front caster wheel allows better maneuverability, while larger rear wheels improve stability and ease of movement, ensuring the device's structural integrity and safety. The wheelchair's compact design ensures maneuverability in tight spaces. The total width allows for easy navigation through doorways and confined spaces, and the overall height offers appropriate support and comfort. Easy to Transport and Its folding frame is built from aluminum, making it lightweight yet durable ensuring longevity. Despite its robust design, it remains lightweight and can be folded into a compact size for easy transport.

    The handrim offers optimal leverage for self-propulsion. The wheelchair's turning radius ensures easy movement in confined spaces, with the pivot width supporting safe turning. Static stability defines the wheelchair's ability to maintain balance on slopes, ensuring safety on inclines and uneven terrains. The angular ranges are consistent with predicate devices and do not raise new questions of safety or effectiveness

    The seat and backrest angles provide ergonomic support, promoting good posture and comfort. Adjustable seat depth and width cater to various body types, while the seat surface height facilitates ease of transfer. The wheelchair includes adjustable footrest and armrest distances, enhancing user comfort and posture.

    Primarily designed for indoor environments but is not suitable for rough terrains.

    The Flexx Junior is tested and compliant with ISO 7176-19 standards, making it suitable as a seat in a motor vehicle. Safety features include push-to-lock brakes, standard anti-tippers, and optional accessories such as a table tray, IV pole holder, and oxygen tank holder. Flip-up, height-adjustable armrests and quick-release axles enhance usability. Engineered to support children throughout their formative years, it provides the perfect balance of flexibility, safety, and comfort as they grow.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1