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510(k) Data Aggregation

    K Number
    K032731
    Device Name
    MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
    Manufacturer
    TURBO WHEELCHAIR CO., INC.
    Date Cleared
    2003-10-30

    (57 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K955553
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA Premarket Notification (510(k)) clearance letter for a manual wheelchair. This type of letter does not include acceptance criteria for device performance, or details of a study proving such criteria are met. The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on safety and effectiveness similarities rather than detailed performance metrics from a new study.

    Therefore, I cannot extract the requested information from the provided document. The sections you asked for, such as acceptance criteria table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, and training set information, are typically found in detailed scientific studies, clinical trial reports, or performance testing summaries, which are not part of this 510(k) clearance letter.

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