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510(k) Data Aggregation

    K Number
    K040824
    Device Name
    INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
    Manufacturer
    BIOMEDICAL LIFE SYSTEMS, INC.
    Date Cleared
    2004-04-29

    (30 days)

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

    INTERFERENTIAL STIMULATOR, MODEL BMLS03-6

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of postsurgical and post-traumatic acute pain.

    Device Description

    Interferential Stimulator Model BMLS03-6

    AI/ML Overview

    The provided text is a 510(k) clearance letter for an Interferential Stimulator, Model BMLS03-6. It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested table and study description based on the provided text. The document is solely a regulatory clearance letter, not a technical report or study summary.

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