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510(k) Data Aggregation

    K Number
    K253632

    Validate with FDA (Live)

    Date Cleared
    2026-01-29

    (71 days)

    Product Code
    Regulation Number
    890.3850
    Age Range
    21 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The manual wheelchair is to provide mobility to persons limited to a sitting position.

    Device Description

    A wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. The device is intended for adults only.

    W50 is a mechanical wheelchair including four wheels, a steel frame cover black paint and a textilene upholstery that is flame resistant. W50 has a physical dimension of 1130mm x 840mm x 950mm (depth x width x height) with the seat itself has a dimension of 525mm x590mm x 470mm (depth x width x height). The device has a weight capacity of 227 kilograms, and weighs about 24 kilograms. The color is dark black.

    Occupant mass group of the manual wheelchair belongs to III. Armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle.

    AI/ML Overview

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