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510(k) Data Aggregation

    K Number
    K253896

    Validate with FDA (Live)

    Date Cleared
    2026-03-04

    (89 days)

    Product Code
    Regulation Number
    882.5890
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K162479

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

    EMS: The device is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

    Device Description

    The GUSE01 TENS/EMS is a battery-powered device that delivers pulsed electrical currents through cables and self-adhesive electrodes applied to the skin.

    TENS (Transcutaneous Electrical Nerve Stimulation) is a well-established technology that stimulates nerves through the skin. Electrodes are placed near the area of pain, where high-frequency impulses help block pain signals in the nerve fibers, reducing the perception of pain.

    EMS (Electrical Muscle Stimulation) is also a widely recognized technology.

    Different pre-programmed programs can be chosen for easy treatment of desired body treatment areas according to electrode positioning guide in User Manual. Each program allows for adjustable pulse intensity to suit individual needs. The integrated relax function delivers electrical stimulation that produces a massage-like sensation (MLS) to promote deep relaxation and recovery.

    AI/ML Overview

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