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510(k) Data Aggregation

    K Number
    K974319
    Device Name
    MIGHTY AIR
    Manufacturer
    WHEELCHAIRS OF KANSAS
    Date Cleared
    1998-01-22

    (66 days)

    Product Code
    FNM
    Regulation Number
    880.5550
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MIGHTY AIR

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

    The Mighty*Air is used to help prevent and treat pressure ulcers.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Mighty Air", which is used to help prevent and treat pressure ulcers. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.

    The letter only states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, and that it can be marketed subject to general controls. It does not elaborate on the specific testing or data that supported this determination.

    Therefore, I cannot provide the requested information based on the given text.

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