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    K Number
    K251856
    Device Name
    Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
    Manufacturer
    Everyway Medical Instruments Co.,Ltd
    Date Cleared
    2025-11-21

    (157 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K201335
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1. The Z4 Li-Battery Powered OTC TENS/EMS Combination Stimulator is intended for over-the-counter (OTC) use. It integrates both TENS and EMS functions in a single unit. However, the device can only operate in one mode (either TENS or EMS) at a time; simultaneous operation of both modes is not possible.

    2. TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P19 programs)

    3. EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P20 to P30 programs)

    Device Description

    The Li-Battery powered OTC TENS/EMS Combination Stimulator, model Z4, is a four-channel electrical stimulation device intended for pain relief and muscle training. It delivers electrical current through electrodes placed on the user's skin. Each operating mode delivers a fixed, pre-configured waveform (e.g., asymmetrical bi-phasic square pulse) and output characteristics; users may only adjust intensity and treatment duration within predefined limits.

    The device primarily consists of two components: the stimulation generator and adhesive electrodes. The generator produces the stimulation current, which is delivered to the body via lead wires connected to the electrodes. Depending on the selected mode—TENS or EMS—the device helps achieve either temporary pain relief or improved muscle performance.

    The Z4 includes the following preset programs:

    • TENS Mode (Programs P1–P19): Intended for temporary relief of pain in the lower back, arms, and legs due to exercise or household/work strain. Users are advised to begin with the lowest intensity and gradually increase to a comfortable "tingling" sensation. Each program differs in waveform parameters and may produce varied sensations.

    • EMS Mode (Programs P20–P30): Designed to stimulate healthy muscles to enhance or support muscle performance. These programs cause the muscles to contract and relax. Users should start at low intensity for warm-up and increase gradually as needed.

    The Z4 device package includes the following accessories:

    • Adhesive Electrode Pads × 24
    • Lead Wires × 4
    • USB Cable × 1
    • Instruction Manual × 1
    • Carrying Case × 1
    AI/ML Overview

    N/A

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