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510(k) Data Aggregation

    K Number
    K022925
    Device Name
    ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2002-11-19

    (76 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    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-taumatic acute pain problems.

    Device Description

    Transcutaneous Electrical Nerve Stimulator (TENS) Model BMLS02-10

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (Electro-Nerve Stimulator TENS Model BMLS02-10). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The letter primarily states that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It refers to general regulatory requirements and contacts for further information.

    Therefore, I cannot provide the requested information based on the provided text.

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