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510(k) Data Aggregation

    K Number
    K113231
    Device Name
    WARP10,WARP75
    Manufacturer
    QUANTUM DEVICES, INC.
    Date Cleared
    2012-02-27

    (117 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WARP-75 is a hand held device used for the treatment of chronic pain by emitting energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; to temporarily increase local blood circulation where applied.
    Device Description
    The Quantum WARP Light Delivery System (WARP-75) is used for applying therapy for the mitigation of chronic pain. Quantum Devices, Inc manufactures this light delivery system. These devices are solid state and hand held for . placement directly over the skin where the treatment is to occur.
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    K Number
    K032229
    Device Name
    QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
    Manufacturer
    QUANTUM DEVICES, INC.
    Date Cleared
    2003-09-12

    (53 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum WARP 10 Light Delivery System is a hand held device used for the treatment of chronic pain by emitting energy in the Near-IR spectrum 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 applied.
    Device Description
    The Quantum WARP 10 Light Delivery System is used for applying therapy for the mitigation of chronic pain. These light delivery systems are manufactured by Quantum Devices, Inc. These devices are solid state and hand held for placement on the area where treatment is to occur.
    Ask a Question

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