Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051046
    Device Name
    PAINACEA MODEL XR8 INFRARED HEAT LAMP
    Date Cleared
    2005-05-10

    (15 days)

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

    ATLANTIS LUMINESCENT PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Painacea Model XR8 infrared heat lamp is intended to emit energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
    Device Description
    The Painacea Model XR8 consists of a collection of near and infrared diodes [LEDs], packaged in a compact handheld device. The system emits light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. The battery and operating system is contained within the handheld device. The device has a cradle with wall power supply to recharge the battery.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1