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510(k) Data Aggregation

    K Number
    K012508
    Device Name
    MU PHOTONICS PAIN THERAPIST
    Manufacturer
    Date Cleared
    2001-10-09

    (64 days)

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

    NU PHOTONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This unit may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This unit may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
    Device Description
    The Nu Photonics Pain Therapist consists of a collection of both infrared and red diodes packaged in a compact plastic case. The system emits pulsed light in the infrared spectrum to provide topical heating, arranged in an area covering just over 11 square inches. The red diodes provide a visible indication that the unit is in operation. The system incorporates an "Auto Off" feature, in the event that the user may inadvertently leave the device on.
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