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510(k) Data Aggregation

    K Number
    K020002
    Date Cleared
    2002-03-21

    (78 days)

    Product Code
    Regulation Number
    890.3800
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the P-33 is to provide mobility to adults with the capacity to maintain a seated position on the scooter and have the capacity to operate a simple hand control.

    Device Description

    Model P-33, Three Wheel Electric Scooter

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a "P-33, Battery Operated, Three-Wheel Electric Scooter." This document is a regulatory approval, not a scientific study describing acceptance criteria and device performance data from a clinical trial or evaluation study.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from the provided text. The document does not contain any of these technical details about device testing or evaluation.

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