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.

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.

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The Dermatrix Duo is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

The SFR applicator is indicated for:

• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation

The Dermatrix Duo system includes the system main body, a footswitch and two handpieces, the Microneedle RF (MFR) and the Superficial RF (SFR). The MFR handpiece is a microneedling handpiece that has 2 different configurations of cartridges: a 16 needle and a 49 needle. The SFR handpiece has 1 configuration consisting of 64 non-invasive tips. The control panel is equipped with an LCD touch screen so that users may easily adjust parameters for optimal settings. The software provides device and clinical information to the users.

The MFR handpiece creates heat within the target dermal tissue via micro needles inserted into the tissue. The microneedle cartridges are sterilized using ethylene oxide.

Using the SFR handpiece, the Dermatrix Duo system creates heat within the target dermal tissue via a matrix of electrodes on the SFR tip. There is only one type of handpiece tip (8x8 RF electrodes) that is non-sterile.

RF energy is delivered to the target tissue using the handpiece, the tip of the handpiece being placed in light contact with the epidermis, and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electrothermal reaction which is capable of achieving controlled coagulation of the target tissue.

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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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