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510(k) Data Aggregation

    K Number
    K061476
    Device Name
    ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2006-07-26

    (57 days)

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

    ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1

    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

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes for test sets or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established.

    Therefore, I cannot provide the requested table and details as the input document does not contain this type of information. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

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