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EMS is used for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis TENS is used for: - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable. EVE Synergy has Synergy mode and Pro mode. Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃. Pro mode has low frequency function that uses the Pro handpiece with tip. It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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SmartAppGuided™ MicroCurrent Face-Lift Pen | 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.

SmartAppGuided™ MicroCurrent Face-Lift Pen| 6 in 1 is an over-the-counter stimulation device. Its enclosure is injection-molded thermoplastic resin with silicone embedded in it. The output contacts consist of an electrode composed of chrome-plated or titanium- gold plated sphere. The device is powered by a rechargeable lithium-ion battery and cannot be used while charging. The device produces microcurrent that is discharged through two fixed, smooth spherical electrodes, and it has 3 current intensity levels that can be adjusted by pressing the on/off button on the device. Press the on/off button to turn on the device, and two spherical electrodes provide low-level electrical pulses to the target position of the face, and when the EMS function is turned on, the vibration function is also turned on simultaneously; The device spheres are designed for optimal contact with facial skin. The device delivers microcurrent as a constant biphasic square wave comprised of 10 positive pulses followed by 10 negative pulses. The microcurrent output continuously alternates between the positive and negative spherical electrodes.

The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.

The Solawave 2-in-1 Skincare Mini (Model: 61043) is a hand-held, battery-powered device that reduce wrinkles by emitting LED red light (630nm) and infrared light (830nm). The device is powered by a Lithium-Ion rechargeable battery, and it comes with a charging cable, storage bag, and instruction manual. The Solawave 2-in-1 Skincare Mini is a revolutionary device that offers two simultaneous approaches for your skin routine in one handheld device: 1. Red and Near-Infrared Light Therapy 2. Warming function (This function is not for medical purpose)

TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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The BTL-785MJ device with the controller and single-use applicators has the following indications for use: 1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain 2. Muscle re-education 3. Increasing blood flow 4. Maintain or increase mandibular range of motion

The BTL-785MJ is a state-of-the-art electrostimulation and radiofrequency platform with accessories that enables the application of therapy by electrical stimulation. The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The generated electromagnetic field is intended to interact with the tissues of the human body in order to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, muscle re-education, increase blood flow and maintain or increase mandibular range of motion. The BTL-785MJ device consists of the following main components: - Main unit - Handpiece - Holding arm - Connection cables - Single-use applicators - Therapy discomfort button

TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, 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.

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

Patch-TEA is an Over-The-Counter device to be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.

The Patch-TEA device is a non-invasive, battery-operated, over-the-counter transcutaneous electrical nerve field stimulator indicated for use in adult patients for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use. The system includes the following components: Patch-TEA device, charging case, electrode pads, USB charging cable, and Patch-TEA app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The Patch-TEA device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The Patch-TEA device is able to connect with the Patch-TEA app, which is located on a smartphone. The user interface is available on both the Patch-TEA device and Patch-TEA app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the Patch-TEA device and Patch-TEA app located on a smartphone.

PZ-2622 is TENS and EMS Stimulator Mode 1-12: TENS: This mode is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Mode 13-24: EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622E (Mode 1-24) is EMS Stimulator This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622T (Mode 1-24) is TENS Stimulator This device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

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Temporary relief of pain associated with 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.

The Progenix Select Stim (Model: PRO1205-OTC1) device is a portable, battery powered (9 V battery) two channel device designed to provide Transcutaneous Electrical Nerve Stimulation (TENS) for the purpose of the symptomatic relief of pain. The device consists of the TENS stimulator, two lead wires and set of four Skin Electrodes. It provides 10 preset TENS treatment programmes. The programs include four modes of operation: Conventional TENS(Continuous), Burst Mode, Modulation mode and HAN TENS. The device LCD screen shows the information of program, intensity level of each channel and operating time. The electrode pads are cleared by FDA (510(k) number K160138). They are used as an accessory to the TENS device unit, to transmit electrical current to patient skin. The electrodes consist of biocompatible self-adhesive conductive application use. These electrodes are sized 50x50mm and are sold under the model number PRO5050.