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510(k) Data Aggregation

    K Number
    K974585
    Device Name
    IF-727 INTERFERENTIAL STIMULATOR
    Manufacturer
    SKYLARK DEVICE CO., LTD.
    Date Cleared
    1998-03-06

    (88 days)

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

    IF-727 INTERFERENTIAL STIMULATOR

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

    ARE USED FOR THE SYMPTOMATIC RELIEF AND MANAGEMENT OF CHRONIC (LONG TERM) INTRACTABLE PAIN AND AS AN ADJUNCTIVE TREATMENT IN THE MANAGEMENT OF POST SURGICAL AND POST TRAUMATIC ACUTE PAIN PROBLEMS.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the IF-727 Interferential Stimulator. It does not contain information about acceptance criteria, device performance studies, or clinical trial methodology.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance
    2. Sample size used for the test set and data provenance
    3. Number of experts used to establish ground truth and their qualifications
    4. Adjudication method
    5. MRMC comparative effectiveness study results
    6. Standalone performance
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established

    This letter only states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses, which are for symptomatic relief and management of chronic pain, and as an adjunctive treatment for post-surgical and post-traumatic acute pain.

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