LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990230
    Device Name
    ELECTRO-NERVE STIMULATOR TENS, MODEL LX
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    1999-08-19

    (206 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Abbreviated
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Transcutaneous Electrical Nerve Stimulation (TENS) devices 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

    Electro-Nerve Stimulator, Tens, Model "LX"

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for an "Electro-Nerve Stimulator, Tens, Model 'LX'". It confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. The letter only states the regulatory classification, indications for use, and confirms the device can be marketed.

    Therefore, I cannot provide the requested table and information based on the input text. The 510(k) approval letter itself does not detail the technical study data.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1