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510(k) Data Aggregation

    K Number
    K013788
    Device Name
    TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Date Cleared
    2001-12-11

    (27 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 5

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

    The intended use of Travel Ease Electric Scooter, Pioneer 5 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.

    Device Description

    Travel Ease Electric Scooter, Pioneer 5

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Travel Ease Electric Scooter, Pioneer 5," confirming its substantial equivalence to previously marketed devices. It details the regulatory classification, general controls, and the process for marketing the device, but it does not include specific performance criteria or scientific study results.

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