Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808:

Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.

1. The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.
2. The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507:

Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.

1. The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation;
2. The Photon mode: The red light is intended for the treatment of periorbital wrinkles.

Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging.

The device is for home environment use, which has electrodes for microcurrent stimulation (the microcurrent stimulation mode was cleared under K252553) and light emitting diodes for light therapy treatment. Especially, the light therapy function of the device equips both red light (for wrinkles treatment) and blue light (for acne treatment) for model INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, while equips only red light for model INIA-ED001, INIA-ED002, INIA-BLD001, E1507.

To use the device, user should place the treatment head on the face and body (only applicable for microcurrent stimulation mode). The device will automatically shut down after treatment time is over.

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Intended Use / Indications for Use

Over-the-counter use:

actiTENS Mini is intended to be used as:

Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:

• Symptomatic relief and management of chronic, intractable pain
• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
• Relief of pain associated with arthritis

Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.

Prescription use:

actiTENS Mini is intended to be used as:

Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
• Relief of pain associated with arthritis

Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P13 and P15 correspond to TENS mode.

Electrical Muscle Stimulation (EMS), used for the following indications:

• Temporary relaxation of muscle spasms
• Prevent or retard disuse atrophy
• Increase of local blood flow in the treatment area
• Re-educate muscles
• Maintain or increase the range of motion
• Prevention of venous thrombosis of the calf muscles immediately after surgery

Program P9 corresponds to EMS mode.

The actiTENS mini is a connected medical device for transcutaneous electrical nerve stimulation (TENS) intended to treat pain in adults. It also contains an electrical muscle strengthening (EMS) program. It is intended for people over 22 years of age with unimpaired intellectual abilities. The actiTENS mini is fixed directly on the body using a fastening accessory. It adapts to the shape of the body with its flexible design. The actiTENS mini can be used discreetly during daily activities.

The EIG (electrical impulse generator) generates electrical impulses that are diffused in the body through skin electrodes connected to one or two channels via cables available in various lengths. Managing the EIG is done by means of the actiTENS Mobile App that allows users to control the stimulation session by choosing: a stimulation program, the number of channels used, the stimulation intensity for each channel and the stimulation duration.

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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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