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EMS: The Compex Sport Elite 3.0 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the Compex Sport Elite 3.0 programs is not suitable for relabilitation or physiotherapy. TENS: The Compex Sport Elite TENS is intended for: - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities: - The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.

The Compex Sport Elite 3.0 is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Sport Elite 3.0 stimulates motor nerves to stimulate a muscular response. Depending on the parameters of theelectrical impulses (pulse frequency. duration of contraction, duration of rest, and totalsession duration). different types of muscle work can be imposed on the stimulated muscles. The Compex Sport Elite 3.0 may therefore be considered a technique of muscletraining. TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering. The Compex Sport Elite 3.0 system consists of these components: - 1x Stimulator - 1x Lead WireSet - 2x Small Performance Snap Electrodepackages ● - 2x Large Performance Snap Electrodepackages - 1x Charging Cable ● - 1x Carrying Case ● These components are packaged together in a carrying case along with the user guide and a battery charger. The electrodes are supplied by Axelgaard Mfg. Co., Inc. and cleared under K130987. The stimulator is a microprocessor controlled 4-channel electro-stimulator. The stimulator drives each output channel independently based upon the parameters predefined for a program selected by the user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments ) Menu), tune a selected program (Stimulation Menu), andadiust the stimulation intensities (Level Menu).

EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy. TENS: The Compex Sport Elite TENS is intended for: · Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities · They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.

The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training. TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering. The Compex® Sport Elite system consists of these components: - 1x Stimulator - 1x Lead Wire Set - 2x Small Performance Snap Electrode package ● - 2x Large Performance Snap Electrode package - 1x Battery Charger ● These components are packaged together in a carrying case along with the user guide and a battery charger. The stimulator is a microprocessor controlled 4 channels electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).

The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction. duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training. Compex Wireless USA as a TENS device is used for: - temporary relief of pain associated with sore and aching muscles due to strain from exercise or . normal household and work activities. - the symptomatic relief and management of chronic, intractable pain and relief of pain associated ● with arthritis.

The Compex Wireless USA employs programs for neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS). TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering. The Compex Wireless USA device stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training. The device system is made up of a remote control. 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter. The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery. The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery. The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control. like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.

Prescription Use: The Strive™ TENS device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain. As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis Over the Counter Use: The Strive™ TENS device is used for: -temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. -the symptomatic relief and management of chronic, intractable pain associated with arthritis.

The Strive device is a handheld Transcutaneous Electrical Nerve Stimulation (TENS) unit which delivers electrical pulses transmitted by electrodes to cutaneous (surface) and afferent (deep) nerves of the body for pain management. The device provides simple user interface and programming, and is aimed to be used with lead wires and electrodes. Strive will be marketed as either Prescription (RX for U.S. Only) or Over-the-Counter (OTC), with each configuration having its own set of labeling, as appropriate. The Strive device utilizes electrodes which are single patient use only. The device embeds a rechargeable battery that cannot be removed. The device is inoperable while the battery is charging.

The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional. Indications for Use: As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain As a pulsed mode device, indications are for the following conditions: - Relaxation of muscle spasm - Increasing local blood circulation - Retardation or prevention of disuse atrophy - Maintenance or increase of range of motion

The Chattanooga Revolution Wireless is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Chattanooga "Revolution Wireless stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter. The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery. The Chattanooga® Revolution Wireless stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450 [mAh] battery. The docking station is the part on which all the other components (modules, remote and accessories) are stored when the Chattanooga Revolution Wireless system is not in use. The docking is continuously connected to an AC wall socket and it allows charging simultaneously the 4 stimulation modules and the remote control. The docking main part is intended to be fixed and not for transportation purposes, but the tablet may be removed and used as a portable charging station for the remote and modules. The docking station includes a removable tray where the user can store electrodes, quick start guide, the remote and modules for transportation. The wireless protocol of the Chattanooga® Revolution Wireless Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.

For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation. Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.

The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.

The Compex Wireless USA is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training. The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter. The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery. The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery. The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.

For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS) - 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 Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HAN - Symptomatic relief or management of chronic, intractable pain - Post-traumatic acute pain - Post-surgical acute pain For DC Continuous Mode - Relaxation of muscle spasm For FES - Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait For EMG triggered Stim - Stroke rehab by muscle re-education - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increase local blood circulation - Muscle re-education - Maintaining or increasing range of motion For EMG - To determine the activation timing of muscles for: - Retraining of muscle activation - Coordinating of muscle activation - An indication of the force produced by muscle for control and maintenance of muscle contractions - Relaxation muscle training - Muscle re-education For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: - Relief of pain, muscle spasms and joint contractures - Relief of pain, muscle spasms and joint contractures that may be associated with : - -Adhesive capsulitis - Bursitis with slight calcification - -Myositis - Soft tissue injuries - Shortened tendons due to past injuries and scar tissues - Relief of sub-chronic and chronic pain and joint contractures resulting from: - Capsular tightness - Capsular scarring For Infrared Lamp (laser) To provide topical heating for the following: - Temporary increase in local blood circulation - Temporary relief of minor muscle and joint aches, pains and stiffness - Relaxation of muscles - Temporary relief of muscle spasms - Temporary relief of minor pain and stiffness associated with arthritis

The Vectra Neo Clinical Therapy System is an electrotherapy product offering clinicians a modular design of muscle stimulation, ultrasound, laser and biofeedback modalities in one combination device. The Vectra Neo Clinical Therapy System is designed to give the most treatment options in one compact and integrated package. The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides three storage drawers to conveniently house clinical essentials. The leadwire management system allows for easy, quick access in an uncluttered arrangement. The electrotherapy module offers 12 waveforms: Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), Microcurrent, VMS, VMS Burst, VMS FR, Russian, High Voltage Pulsed Current, Symmetrical Biphasic (TENS), Direct Current, and HAN (TENS). The Vectra Neo Clinical Therapy System allows to sequence these waveforms for ease of use. The Neo ultrasound module is dual frequency (1 MHz and 3.3 MHz) with selectable duty cycles of 10%, 20%, 50% and 100%, low BNR (5.0:1) {FDA method of measurement), pulse frequency 100Hz and selectable pulse durations of 1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%. The laser therapy module is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relaxation of muscles, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis. The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto a USB Thumb Drive. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education. Online guided assistance is provided through Clinical Protocol Setup and On-Screen Indications to help guide therapy selections for electrotherapy waveform rationale, parameter selections, electrode placement images, laser and ultrasound applicator recommendations. Combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), VMS, VMS Burst, VMS FR and High Voltage Pulsed Current.

Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home.

The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device designed to apply rapid inflation with graduated sequential compression to a patient's calf, thigh or foot for the purpose of assisting blood flow in the veins. This rapid inflation and graduated, sequential compression device accelerates venous velocity and enhances fibrinolysis. The Aircast VenaFlow Elite System provides two different modes for inflation. The system defaults to Standard Operation which inflates the cuffs one leg at a time, alternating between the two legs once every 30 seconds. The cuffs inflate within less than 0.5 seconds. The system has an alternate S Mode which inflates both cuffs at the same time, once every 60 seconds. The cuffs inflate in approximately 10 seconds. The Aircast VenaFlow Elite System provides the user with an option of battery operation in addition to operation from the mains power. The Aircast VenaFlow Elite System is easy to use and provides the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs. The Aircast VenaFlow Elite System is available in two configurations. The CLINICAL configuration is for medical facilities and offers the full range of accessories including cuffs, varying tube lengths, optional battery and replacement kits. The HOME configuration is for home use and is provided with simplified patient instructions and offers a specific set of accessories limited to calf cuffs and tubing.

As an NMES device, indications are for the following conditions: - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis As a pulsed current device, indications are for the following conditions: - Reduction of edema (under negative electrodes) - Reduction of muscle spasm - Influencing local blood circulation (under negative electrode) - Retardation or prevention of disuse atrophy - Facilitation of voluntary motor function - Maintenance of increase of range of motion

The Empi Phoenix is a multifunctional electrotherapy device indicated for retarding or preventing disuse atrophy, maintaining or increasing range of motion, and re-educating muscles. The Empi Phoenix device provides two channels of neuromuscular electrical stimulation (NMES), transcutaneous electrical stimulation (TENS) for pain management, and a pulsed DC Edema program to increase local blood circulation and reduce edema (swelling). These programs allow the patient to receive electrotherapy throughout the recovery cycle using a single device. Its simplified programming makes the Empi Phoenix device convenient for home use: after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to begin therapy. The device may be used with conventional leadwires and electrodes. For NMES treatment, it also may be paired with the Empi Phoenix™ Thigh Garment (provided as an accessory), which is designed to make electrode placement and treatment of the knee/quadriceps easier for the patient and clinician.