LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K241723
    Device Name
    Electric wheelchair (W3902)
    Manufacturer
    Zhejiang Richall Medical Technology Co., Ltd.
    Date Cleared
    2024-09-05

    (83 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

    Electric wheelchair (W3902)

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Electric wheelchair (W3902)". This document does not contain information about the acceptance criteria and study details for an AI/ML device. It focuses on regulatory approval based on substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1