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510(k) Data Aggregation

    K Number
    K240331
    Device Name
    Electric wheelchair (YHWL002, YHWL003)
    Manufacturer
    Yongkang Youha Electric Appliance Co.,Ltd.
    Date Cleared
    2024-10-01

    (239 days)

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

    The Electric 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

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the "Electric wheelchair (YHWL002, YHWL003)" (K240331) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically associated with AI/ML-driven medical devices.

    This document is a standard FDA clearance letter for a Class II medical device (Powered Wheelchair). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to. It does not include details about clinical performance studies or specific metrics that would be relevant for answering your detailed questions about acceptance criteria and study methodologies for an AI device.

    Therefore, I cannot provide the requested information based on the given input.

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