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510(k) Data Aggregation

    K Number
    K251565
    Device Name
    Wheelchair (N817)
    Manufacturer
    ZHEJIANG TOPWE TOOLS MANUFACTURING CO.,LTD
    Date Cleared
    2025-10-06

    (137 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K230964
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

    Device Description

    The product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm. The electric wheelchair is classified as class A and the maximum occupant mass is 120kg. The Electric Wheelchair is a battery powered vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator light, ON/OFF button, horn button, speed indicator, speed increase button, speed decrease button, joystick, battery charger socket), arm supports, push handle, two rear wheels, two casters(front wheels), foot supports, anti-tip devices. The wheelchair can easily fold and unfold for transportation or storage.

    AI/ML Overview

    N/A

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