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510(k) Data Aggregation

    K Number
    K121363
    Device Name
    DIOWAVE LOW LEVEL COLD LASER SYSTEM
    Manufacturer
    TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA)
    Date Cleared
    2012-11-23

    (200 days)

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

    TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diowave Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
    Device Description
    Not Found
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