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510(k) Data Aggregation

    K Number
    K254206

    Validate with FDA (Live)

    Device Name
    Power wheelchair (ZS-EW8026)
    Manufacturer
    Ningbo Zhishan Medical Technology Co., Ltd.
    Date Cleared
    2026-03-27

    (88 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K250158
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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 power wheelchair is classified as class A and the maximum occupant mass is 150kg.

    The power wheelchair is a battery powered four wheeled vehicle.

    It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back cushion, control system, armrest, two rear wheels, two casters(front wheels), foot pedal, anti-tip devices.

    The power wheelchair can easily fold and unfold for transportation or storage.

    AI/ML Overview

    N/A

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