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

EMS(Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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TENS:
The device is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities.

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

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The Veinoplus® Back is to be used for temporary relief of pain associated with sore and aching muscles in the back (shoulder, middle of the back, or lumbar area), due to strain from exercise or normal household and work activities.

VEINOPLUS Back is a non-invasive, battery-operated, over-the-counter device that provides transcutaneous electrical nerve stimulation (TENS). The VEINOPLUS Back consists of the handheld device with LCD screen and button controls, self-adhesive electrodes, cable to connect the device to the electrodes, 9V battery, and optional carrying accessories. When the device is in use, the on/off status, battery indicator, and stimulation intensity are displayed on the device's screen. The user is able to control the stimulation intensity via the button controls on the device and the device includes safety features such as automatic shut-off and patient override control.

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Multi-functional Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial stimulation through MC(micro-current) mode.

The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.

a. Micro-current stimulation function.
b. Red LED irradiation function. (Cleared under K252142).
c. Blue LED irradiation.(Cleared under K252142).
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress(39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress(35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function(motor vibration).(The vibration is classified as class I and not need for 510K).

Each mode of the device is independent from all other modes of the Multi-functional Facial Beauty Device.

The Multi-functional Facial Beauty Device consists of a main unit, USB charging cable, components shown as following illustration: (Here takes model SKB-2109 and model SKB-2129 as examples)

SKB-2109:

• Intensity indicator
• Mode indicator
• Intensity button
• OFF/ON& Mode switch button
• Massage head
• LED light
• Massage head
• USB charging cable

SKB-2129:

• LEDs (Red)
• Massage head
• Power/Mode/Intensity Button
• RED LIGHT Indicator
• MC Indicator
• Intensity Indicator
• USB charging cable

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The Aura Glide is an over-the-counter handheld device for aesthetic purposes.
(1) The microcurrent mode is indicated for facial stimulation.
(2) The LED mode is intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate inflammatory acne (blue light).

Aura Glide is a lemon shaped handheld device that consists of:

• A main control body that is programmed with preset treatment modes depending on the application at the time of use.
• Two (2) essential attachments that are detachable. Each attachment is specifically designed to sit securely on the main body to ensure proper functionality and stability during use.
  • LED (Light Emitting Diode) Attachment – intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate acne (blue light).
  • Microcurrent Attachment – indicated for facial stimulation. Microcurrent can be delivered with three (3) levels of intensity; L1 (Gentle; Default), L2 (Standard), and L3 (Strong) depending on user preference.
• Conductive gel (Glide On Primer gel) must be applied prior to starting microcurrent treatment. It enhances conductivity ensuring safe and effective microcurrent treatment.
• The Aura Glide is equipped with a USB-C charging port located on the bottom of the device and an internal rechargeable battery. A USB-C charging cable is provided with every device.

The Aura Glide is an over-the-counter cosmetic device for home use.

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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.

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.

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Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.

Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 14 programs (11 standard programs and 3 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K213879). Size: 50*50mm.

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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)

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

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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.

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.

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The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift Essential Eye Mask ("Medi Lift Eye") is composed of a mask made of silicone rubber which is worn on the upper part of the user's face, and covers the upper cheek and the periocular region outside the orbital rim. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The mask also contains a heater to warm the upper cheek area for user relaxation, not for a medical purpose. The stimulation and heating functions are provided in separate modes and cannot be used simultaneously. The controllers attached to the mask contain two charging pins which allow for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable that is provided as part of the device. The device is not operated during charging.

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