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510(k) Data Aggregation

    K Number
    K011751
    Device Name
    TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
    Manufacturer
    MERITS HEALTH PRODUCTS., INC.
    Date Cleared
    2001-08-06

    (61 days)

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

    TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3

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

    The intended use of the MERITS Pioneer 3 Powered Scooter is to provide mobility to adults, limited to a siting position and have the capability to operate a simple hand control.

    Device Description

    MERITS Pioneer 3 Electric powered four wheel drive scooter

    AI/ML Overview

    Due to the nature of the provided document, which is an FDA 510(k) clearance letter for a powered scooter, the requested information about acceptance criteria and a study proving a device meets acceptance criteria using AI/ML methodologies is not present.

    This document pertains to a physical medical device (MERITS Pioneer 3 Electric Powered Four Wheel Drive Scooter) and its clearance through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device. It does not involve AI/ML performance studies, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML-driven medical devices.

    Therefore, I cannot extract the requested information as it is not contained within the provided text.

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