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510(k) Data Aggregation

    K Number
    K082951
    Device Name
    IMMERSION HYDROBATH
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Date Cleared
    2009-04-08

    (187 days)

    Product Code
    ILJ
    Regulation Number
    890.5100
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARJO HOSPITAL EQUIPMENT AB

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

    To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an "Immersion hydrobath." It signifies that the device is substantially equivalent to a legally marketed predicate device. However, this type of regulatory document does not typically contain the detailed information required to describe acceptance criteria and a study proving device performance as requested.

    The letter focuses on regulatory approval, referencing existing regulations and indicating that the device can be marketed. It does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a specific study (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information).

    Therefore, based solely on the provided text, I cannot extract the information required to answer your prompt. This document is a regulatory approval, not a performance study report.

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