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510(k) Data Aggregation

    K Number
    K071284
    Date Cleared
    2007-07-26

    (80 days)

    Product Code
    Regulation Number
    890.3800
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Segaego 3D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the "Scooter Segaego 3D," a motorized three-wheeled vehicle. This document does not contain any information regarding acceptance criteria, device performance results, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

    The letter primarily focuses on the regulatory aspects of the device, stating that it has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

    Therefore, I cannot provide the requested information from the provided text.

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