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510(k) Data Aggregation

    K Number
    K970081
    Device Name
    SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
    Manufacturer
    CATHAY CONSOLIDATED, INC.
    Date Cleared
    1997-11-07

    (302 days)

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

    CATHAY CONSOLIDATED, INC.

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

    The Cathay Consolidated Super Air 9000 is indicated for the prevention and treatment of pressure ulcers ( bed sores).

    Device Description

    Super Air 9000 Alternating Air Flotation Mattress System

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "Super Air 9000 Alternating Air Flotation Mattress System." This document grants permission to market the device based on its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI-powered device or its performance metrics.

    The letter focuses on regulatory approval, classification, and general controls applicable to the device. It states the indications for use (prevention and treatment of pressure ulcers) but does not provide performance data or study results.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document.

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