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510(k) Data Aggregation

    K Number
    K021271
    Device Name
    ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS
    Date Cleared
    2003-02-06

    (290 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-traumatic acute pain problems.

    Device Description

    (TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS02-3

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device called "Electro-Nerve Stimulator TENS Model BMLS02-3." This type of document determines substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, or details like sample size, expert qualifications, or ground truth establishment.

    Therefore, I cannot extract the requested information from the provided text. The document is strictly a regulatory approval letter based on substantial equivalence.

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