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510(k) Data Aggregation

    K Number
    K082223
    Device Name
    NEUTROLUMENPN SYSTEM, MODEL 1000
    Manufacturer
    NEUROLUMEN, LLC
    Date Cleared
    2009-04-21

    (258 days)

    Product Code
    ILY,GZJ
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEUTROLUMENPN SYSTEM, MODEL 1000

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

    LED Stimulation for therapeutic heat

    The NeurolumenPN is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated

    TENS Stimulation

    The symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.

    Device Description

    NeurolumenPN System, Model 1000

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the NeurolumenPN device. This document confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.

    Therefore, I cannot provide the requested table and study details. The document is primarily an FDA communication approving the marketing of the device, not a technical report on its performance or the studies conducted for that purpose.

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