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510(k) Data Aggregation

    K Number
    K252825

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (91 days)

    Product Code
    Regulation Number
    890.3850
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The W45 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

    Device Description

    The W45 Manual Wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by a caregiver using the rear push handles. The device is intended for adults only (age ≥22 years). W45 is a mechanical wheelchair including four wheels, features an aluminum frame, polypropylene hand grip and foot pedals, and a nylon upholstery that is flame resistant. W45 has a physical dimension of 1010mm × 610mm × 920mm (overall length × overall width × handgrip height) with the seat itself has a dimension of 470mm × 457mm × 449mm (effective depth× effective width × height at front edge). The device has a weight capacity of 115 kilograms, and weighs about 12 kilograms. The armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle. The device features hand brake levers on the rear push handles, with a squeeze-locking mechanism that functions as a parking brake.

    AI/ML Overview

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