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510(k) Data Aggregation

    K Number
    K102304
    Device Name
    BREEZE C MODEL C (3W), BREEZE C (4W)
    Manufacturer
    AFIKIM ELECTRIC VEHICLES
    Date Cleared
    2011-01-07

    (144 days)

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

    BREEZE C MODEL C (3W), BREEZE C (4W)

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

    The Breeze C, 3&4 wheels Scooter is intended to provide increased mobility for the elderly and/or disabled persons. The Breeze is also suite for the use of elderly persons and physically disabled persons.

    Device Description

    Breeze C, 3&4 wheels Scooter

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a medical device (Breeze C, 3&4 wheels Scooter), not a study report or clinical trial
    document. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study
    details, sample sizes, expert qualifications, or ground truth establishment.

    A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather
    than proving performance against specific acceptance criteria through a clinical study as would be detailed in a separate
    performance testing report or clinical trial submission.

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

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