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510(k) Data Aggregation

    K Number
    K033923
    Device Name
    TH0R DDII IR LAMP SYSTEM
    Manufacturer
    THOR INTL.
    Date Cleared
    2004-03-17

    (90 days)

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

    THOR INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The THØR DDII 1R Lamp System is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
    Device Description
    The THØR DDII IR Lamp System is a portable, AC and battery operated noninvasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency. The System consists of a Drive Unit/Power Supply that houses the electronics and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit.
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    K Number
    K030226
    Device Name
    THOR DDII 830CL3 LASER SYSTEM
    Manufacturer
    THOR INTL.
    Date Cleared
    2003-02-10

    (19 days)

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

    THOR INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The THØR DDII 830CL3 Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
    Device Description
    THØR DDII 830CL3 Laser System is a handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser that is intended for use as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. The THØR 830CL3 Laser System incorporates three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90 milliwatts (mW) at 830 nanometer (nm) wavelength.
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