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510(k) Data Aggregation

    K Number
    K033455
    Device Name
    ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-01-15

    (77 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 BMLS03-5

    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

    (TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS03-5

    AI/ML Overview

    I'm sorry, but this document is a letter from the FDA regarding a 510(k) premarket notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the device's substantial equivalence to legally marketed predicate devices.

    This document does not contain information about:

    • Acceptance criteria or reported device performance.
    • Any specific study details such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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