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510(k) Data Aggregation

    K Number
    K142025
    Device Name
    NEUROLUMEN PN-1000
    Manufacturer
    NEUROLUMEN, LLC
    Date Cleared
    2015-01-21

    (180 days)

    Product Code
    ILY, GEX, GZJ, ISA, NHN
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROLUMEN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neurolumen is indicated for the 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. The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
    Device Description
    The Neurolumen is a medical therapy device that delivers Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT) to a patient's limbs. The Neurolumen consists of a control unit and six wraps. Each wrap contains two laser diodes, 4 light emitting diodes, and one or two TENS gel pads. After applying the wraps to the feet, ankles, and legs, the control unit is able to provide up to 30 minutes of therapy on a single charge of the internal lithium-ion battery. A charger is provided for recharging the internal battery.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROLUMEN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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