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510(k) Data Aggregation

    K Number
    K252494

    Validate with FDA (Live)

    Date Cleared
    2025-12-05

    (119 days)

    Product Code
    Regulation Number
    890.3860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Electrically powered wheelchair 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 Electrically powered wheelchair mainly consists: a frame (a front wheel bracket, a motor frame, a seat frame, a backrest frame), armrests, a controller, a driver, a seat cushion, a back cushion, footrests, 4 wheels, 2 back wheel motors, 2 anti-tilt wheels, a safety belt and 2 lithium batteries.

    The device is composed of two sets of four-bar linkage hinges, which can be unfolded and folded. After unfolding, the two sets of four-bar linkage are locked by a locking structure.

    The device is installed with an electromagnetic brake that will engage automatically when the device is not in use and the brake cannot be used manually. The device only can be operated on the flat and hard road.

    AI/ML Overview

    N/A

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