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510(k) Data Aggregation

    K Number
    K252273

    Validate with FDA (Live)

    Device Name
    Therapy US
    Manufacturer
    Dmc Importação E Exportação DE Equipamentos Ltda
    Date Cleared
    2025-12-12

    (143 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K241057
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Therapy US is generally indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

    Device Description

    The Therapy US consists of an ergonomic device that is easy to use and operate. The device has a red laser diode (660 nm) and an infrared laser diode (808 nm). 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.

    The Therapy US should be used by doctors, nurses, and physical therapists for adjunctive use in temporary pain relief of minor chronic neck and shoulder pain in patients.

    The Therapy US consists of components including a handpiece, handpiece holder, battery charging cable, spacer (3 units), safety glasses, eye protection, and carrying case. The only part that comes into contact with the patient is the spacer. This component is made of polycarbonate, and its function is to create a safe distance between the tip of the therapy device and the patient's skin.

    AI/ML Overview

    N/A

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