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510(k) Data Aggregation

    K Number
    K241721
    Date Cleared
    2024-09-05

    (83 days)

    Product Code
    Regulation Number
    890.3860
    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 (N3901)

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an electric wheelchair. It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it is not a technical report for the device's performance, but rather a regulatory approval document.

    Therefore, I cannot provide the requested information. The concepts mentioned (acceptance criteria, test sets, ground truth, MRMC studies, training sets) are relevant to the evaluation of certain types of medical devices, particularly those involving AI or diagnostic capabilities, which is not the case for an electric wheelchair as described here. An electric wheelchair would typically be evaluated based on safety standards, maneuverability, battery life, weight capacity, etc., rather than the type of criteria you've listed.

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