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510(k) Data Aggregation

    K Number
    K013532
    Device Name
    ULTRASTIM KIT
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Date Cleared
    2002-08-22

    (309 days)

    Product Code
    GZJ,GXY,IQE
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRASTIM KIT

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

    The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "UltraStim Kit." It confirms the device's substantial equivalence to predicate devices for its intended use. This type of document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria.

    Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) from this document. This letter is a regulatory approval notice, not a study report.

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