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510(k) Data Aggregation

    K Number
    K243131
    Device Name
    Triathlon Pro
    Manufacturer
    Date Cleared
    2025-11-07

    (403 days)

    Product Code
    Regulation Number
    882.5890
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TENS: The device is designed to be used for temporary relief of pain associated with the sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

    EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

    Device Description

    The Globus Triathlon Pro TENS and EMS stimulator is an over-the-counter transcutaneous electrical nerve stimulator and electronic muscle stimulator (TENS/EMS) device providing peripheral nervous system stimulation and muscular electrostimulation in order to reduce atrophy, spasticity, and to increase muscular power. It can be used for arm, shoulder, neck, back, waist, abdomen, and legs.

    The stimulation channels transfer the desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing muscle contractions. The accessory electrodes are FDA-cleared. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to the patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.

    The Triathlon Pro provides electro stimulation through the surface electrodes. Electrode position during electro stimulation depends on the body part involved and on the type of program that is being carried out. For all programs that cause significant muscle contraction, it is important to place the electrode on the muscle motor point, which is the most sensitive to stimulation. The electro stimulator keeps track of the last 10 executed programs so that they are available for very simple and fast execution. Recording takes place automatically at the end of the execution of a program.

    Electrostimulations are designed to be used in domestic environments, clinics, physiotherapy centers, rehabilitation in general, pain treatments in general, for aesthetic and sport purposes. The user of this device must be adult.

    AI/ML Overview

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