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510(k) Data Aggregation

    K Number
    K030275
    Device Name
    MB SYSTEM, BIOENERGY LIGHT THERAPY
    Manufacturer
    Date Cleared
    2004-11-29

    (672 days)

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

    AMEST CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain, spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.
    Device Description
    The MB BioEnergy Light Therapy System provides easy to use front pancl controls and display for the operation of an array of infrared light emitting diodes that can apply topical heat to areas of the patient body. The user can set the frequency of oscillation, intensity level, and time of operation to control delivery of the radiation.
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