LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133443
    Device Name
    MARATHON NO STING LIQUID SKIN PROTECTANT
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
    Date Cleared
    2014-07-10

    (240 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MARATHON NO STING LIQUID SKIN PROTECTANT

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

    Marathon No Sting Liquid Skin Protectant is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing).

    Marathon No Sting Liquid Skin Protectant helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against irritation caused by adhesive products.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a premarket notification for a medical device (Marathon No Sting Liquid Skin Protectant). It discusses the regulatory classification and general controls applicable to the device.

    However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness studies for an AI/algorithm-based medical device.

    Therefore, I cannot fulfill your request for this information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1