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510(k) Data Aggregation

    K Number
    K252154

    Validate with FDA (Live)

    Date Cleared
    2025-12-09

    (153 days)

    Product Code
    Regulation Number
    890.5850
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NMES is used for:
    The device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the NMES programs is not suitable for rehabilitation and physiotherapy.

    The TENS is intended for:
    a) Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;
    b) The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

    Device Description

    The Portable Electro Stimulation Therapy Device (Model: LGT-2320ME, LGT-2320BE, and LGT-2320SP) is an electrotherapy device, mainly consists of the main unit, hand switch and electrodes, providing three channel groups (CH1-CH6, CH7-CH12 and CV Output channel) of TENS or NMES current.

    The device is designed to deliver modulation waveform microcurrent to patient body via electrode pads which are connected to the output channel with lead wire, and the device is supplied by AC mains 100-240 Vac. The control circuit is enclosed in the enclosure of the main unit of the device, with hand switch and power supply driving circuit.

    AI/ML Overview

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