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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.

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    K Number
    K252828

    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 W47 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. W47 is a mechanical wheelchair including four wheels, a steel frame and a seat and back upholstery that is flame resistant. W47 has a physical dimension of 1340mm × 690mm × 950mm (overall length × overall width × handgrip height) with the seat itself has a dimension of 580mm × 450mm × 465mm (effective depth × width × seat height at front edge). The device has a weight capacity of 136 kilograms, and weighs about 24 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 as well as wheel locks (parking brakes).

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