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510(k) Data Aggregation

    K Number
    K020001
    Device Name
    PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
    Manufacturer
    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.
    Date Cleared
    2002-03-21

    (78 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3

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

    The intended use of the PF-3 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

    Device Description

    Model PF-3, Four Wheel Electric Scooter

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a motorized four-wheel power scooter (PF-3). It confirms substantial equivalence to a legally marketed predicate device.

    The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It is a regulatory approval letter, not a scientific study report.

    Therefore, I cannot fulfill your request for the specific information about acceptance criteria and the study proving the device meets them based on the given input.

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