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510(k) Data Aggregation

    K Number
    K991241
    Device Name
    IF8000
    Manufacturer
    Date Cleared
    1999-11-02

    (204 days)

    Product Code
    Regulation Number
    890.5850
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IF8000

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

    In Interferential Mode: Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain. In NMES Mode: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent deep venous thrombosis. Maintaining or increasing range of motion.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (IF8000) dated November 2, 1999. It states that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use in Interferential Mode and NMES Mode.

    However, it does not include details about:

    • Acceptance criteria and reported device performance.
    • The study that proves the device meets the acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number and qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for the training set was established.

    This document is a regulatory approval, not a technical report detailing the device's validation studies.

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