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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.

For Prescription and Home Use by prescription from a medical professional: The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - increasing local blood circulation - immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Muscle re-education As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions: - Helps to relearn voluntary motor functions of the extremities. TrainFES' Advanced intended population is anybody aged 22 or over. Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home. Platform: TrainFES is a battery-powered, wireless device, accessible through software.

TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone. TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.

Quantum Mitohormesis Medical Device is intended for: - Stimulating healthy limb muscles to improve and facilitate muscle performance. - Preventing or retardation of disuse atrophy of muscles.

Quantum Mitohormesis (QMT) is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. Users (adults ≥ 22 years old) place one group of muscles in the lower limbs into the field applicator of QMT device, which for a defined duration generates specific electromagnetic fields that stimulates healthy muscles to improve and facilitate muscle performance, and prevents and retards muscle disuse atrophy. QMT is applied directly to muscles (without direct contact) to stimulate muscle activity. In order to achieve optimized treatment outcome, QMT is applied to muscles on a weekly basis, once or twice a week, with each treatment application lasting a brief 10-minutes. The device consists of the following high-level components: - Base unit, which includes signal generator, power amplifier, and micro-controller unit. - Field applicator, which includes electro-magnetic coils generating specific magnetic pulses. - User Interface Panel, which allows users to operate the device and display necessary device information. - Signal cord. - Height and tilt adjustment knobs, which allow users to adjust the height and tilt of field applicator; and

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

eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable. eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode. MULTI mode has RF and EMS functions that use the MULTI handpiece. In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface. In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43 ℃. EMS mode has an EMS function that uses the EMS handpiece.

BTL-899MS is indicated to be used for: · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - · Strenathening, toning and firming of buttocks, thighs and calves. - · Improvement of muscle tone and firmness, for strengthening muscles in arms. The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The BTL-899MS device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. Indications for Use for Muscle Stimulators: - · Relaxation of muscle spasms - · Prevention or retardation of disuse atrophy - Increasing local blood circulation - · Muscle re-education - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - · Maintaining or increasing range of motion

The BTL-899MS is a non-invasive therapeutic device. The device is comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators. The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying tissue accompanied by a pleasant feeling of warming in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable. The BTL-899MS 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 MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.

MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use. The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique. A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.

PA&PR series: The PA&PR series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator, PA&PR series are indicated for the following conditions: - · Relaxation of muscle spasms, - · Prevention or retardation of disuse atrophy, - · Increasing local blood circulation, - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, - · Maintaining or increasing range of motion, - · Muscle re-education. Environments of Use: Clinics, hospital. Patient population: Adults S&Q series: The S&O series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator, S&Q series are indicated for the following conditions: - · Relaxation of muscle spasms, - · Prevention or retardation of disuse atrophy, - · Increasing local blood circulation, - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, - · Maintaining or increasing range of motion, - · Muscle re-education. As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions: · Symptomatic relief and management of chronic (long-term), intractable pain, - · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. Environments of Use: Clinics, hospital and home environments. Patient population: Adults

Subject device have four series, which are PA series, PR series, Q series and S series. These four series are all electrical stimulating devices.

The accufit is indicated for use for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen, and Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

The principle of operation of the accufit device is to provide direct electrical stimulation of muscles which produces muscle contractions in and around the area of the treatment electrodes. The accufit generates electrical stimulation to contract the muscles to achieve the desired intended use using unique IntelliPhase waveforms and IntelliSTIM electrodes. It offers two unique IntelliPhase waveforms, Biphasic and Interferential (4P), that are designed to optimize muscle re-education and activation for patients. The four IntelliPhase waveform protocols are twist, hold, grip, and tap. Each protocol may be used for 15, 30, or 45 minutes. Not only are there four IntelliPhase protocols, but there is also a fully automated protocol (IntelliCycle) that integrates all the above listed waveforms in a comprehensive, interlaced series. This engages all the targeted muscles in a continuous program to maximize muscle effects with the touch of a button. accufit is both the proprietary-trade name and generic name. accufit is a supplement to existing treatments and does not replace any traditional treatment or therapy. The system console is the heart of the accufit and contains the Touch LCD/GUI, electrodes, and power supply module. The main console also includes a key switch used to turn the power on and off, and an emergency stop push button that quickly de-energizes the system in emergency situations. There are 4 casters in the console base that can be used when moving the system.

This Zynex device has been designed for muscle re-education, prevention of disuse atrophy, increase local blood circulation, maintain, or increase range of motion, and relaxation of muscle spasms.

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The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The BTL-899M device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. Indications for Use for Muscle Stimulators: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

The BTL-899M is a non-invasive therapeutic device. The device is comprised of a main unit and an applicator that deliver electromagnetic energy to the targeted tissue. The device's output enables handsfree treatment. The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying muscles, joints and connective tissue accompanied by a pleasant feeling of warming sensation in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable. The BTL-899M is equipped with a large color touch-screen that significantly 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 easily 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.