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510(k) Data Aggregation

    K Number
    K232813
    Device Name
    Therapy EC, Therapy XT
    Manufacturer
    DMC Importacao e Exportacao de Equipamentos LTDA
    Date Cleared
    2024-12-19

    (463 days)

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

    DMC Importacao e Exportacao de Equipamentos LTDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Therapy EC and Therapy XT are non-heating infrared lamps and are indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
    Device Description
    Therapy EC and Therapy XT are made up of ergonomic equipment that is easy to use and operate. They have one infrared laser diode (808nm). Two optical fibers conduct the laser light emitted by each emitter. The optical power emitted is controlled by the electrical current in the laser diodes. Therapy EC and Therapy XT are designed to emit infrared laser light. Additionally, they are intended to be used by health care professionals such as physicians, nurses, and physical therapists, for adjunctive use in the temporary relief of hand of wrist pain associated with Carpal Tunnel Syndrome. Therapy EC and Therapy XT are consisted of components including handpiece holder, battery charging cable, battery, spacer (3 units), safety glasses, eye protector, and transportation case. The only part that touches the patient is the spacer. This component is made of polycarbonate and has the function of creating a safe distance between the Therapy tip and the patient's skin.
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