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510(k) Data Aggregation

    K Number
    K033460
    Device Name
    CHEETAH WHEELCHAIR
    Manufacturer
    R82 A/S
    Date Cleared
    2004-03-26

    (148 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHEETAH WHEELCHAIR

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

    The Cheetah Wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a medical device: the "Cheetah Wheelchair." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance) of the kind requested.

    The letter is a regulatory document confirming that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them because this information is not present in the provided text.

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