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510(k) Data Aggregation

    K Number
    K070974
    Device Name
    LIGHT RELIEF, MODEL LR150, LR200
    Manufacturer
    LIGHT RELIEF, LLC
    Date Cleared
    2007-05-24

    (48 days)

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

    LIGHT RELIEF, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Light Relief Infrared Lamp is an over-the-counter device intended for use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints. This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. - Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. - Provides temporary relief of minor aches and pains in muscles and joints. - Aids in the relaxation of muscles. - Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. - Provides a temporary increase in local blood circulation.
    Device Description
    The Light Relief Infrared Lamp is a pain relief device consisting of a hand-held module with a flexible pad, containing an array of 59 colored and infrared LED's, and a power supply. Minor design changes have been made to the device, including: an increase in the pad size and number of LEDs; addition of rechargeable battery option, automatic shut off feature, internal heating element and frequency options; and changes to the pad material, pad attachment method and body strap closure method.
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