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510(k) Data Aggregation

    K Number
    K012643
    Device Name
    APEX MEDICAL LCD TENS-VII
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2001-10-29

    (77 days)

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

    APEX MEDICAL LCD TENS-VII

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

    LCD TENS-VII is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

    Device Description

    Not Found

    AI/ML Overview

    The provided document describes the FDA's 510(k) clearance for the "Apex Medical LCD TENS-VII" device. It is a regulatory letter stating that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use.

    This document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The letter focuses on the regulatory clearance process and confirms that the device can be legally marketed based on its substantial equivalence to existing devices. It does not include the technical details of any performance studies.

    Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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