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The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use: - · Relaxation of muscle spasms - · Re-education of muscle - · Prevention or retardation of disuse atrophy - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Increases local circulation - · Maintains or increases range of motion Stimulator waveforms: IFC, LVPC, and VMS: · Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury. Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use: - Relieves pain - · Decreases joint stiffness and contractures - · Reduction of muscle spasm - · Increases local circulation - · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues - · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring

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ELECTROTHERAPY VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Microcurrent, Interferential, Premodulated (IFS), VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute pain and post-surgical acute pain. FES is indicated for 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. DC Continuous Mode is indicated for relaxation of muscle spasm. ULTRASOUND THERAPY Ultrasound module is indicated for an 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 capsultis, with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues; relief of sub-chronic pain and joint contractures resulting from: capsular tightness, capsular scaring. LASER THERAPY Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief of minor pain and stiffness associated with arthritis.

BTL-4000 is a professional physiotherapy device. Depending on the required configuration, the device can consist of up to three generators - electrotherapy, ultrasound therapy and laser therapy. Electrotherapy is a non-invasive therapeutic method based on electrical current flow through the human tissues. The electric current is applied with the use of electrodes directly through the patient's skin. The use of electrotherapy is accepted in the field of rehabilitation. Ultrasound therapy is a non-invasive therapeutic method, which uses mechanical energy of the longitudinal waves penetrating deep through human soft-tissues. Mechanical waves are absorbed in the tissues and transformed into heat energy.Low-level laser therapy is a noninvasive therapeutic method based on the application of coherent, polarized, monochromatic light in the form of a laser beam. The laser beam is absorbed in the tissues. BTL-4000 is equipped with a colour touch screen, which considerably simplifies its operation. Therapy is simply started by a quick selection from the list of the most frequently used therapeutic protocols or by selecting from the list of all therapeutic protocols. A sophisticated function of the device is the possibility to select the optimum therapy according to the required therapeutic effect or according to the place of application. The BTL-4000 consists of the following main components: - . control unit - user interface with 7" LCD color touch screen ● - therapy modules electrotherapy, ultrasound and laser . - accessories depends on the combination - electrotherapy electrodes - laser probe/cluster - । ultrasound head/HandsFree sono handpiece

Therapeutic Ultrasound - Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as: - 1. Pain relief, muscle spasms and joint contractures. - 2. 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 - 3. Relief of sub-chronic, chronic pain and joint contractures resulting from: - · Capsular tightness - · Capsular scarring For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: - 1. Symptomatic relief of chronic intractable pain - 2. Post-traumatic acute pain - 3. Post-surgical acute pain Additionally for NMS. NMS Burst, Hi-Volt and Russian: - 1. Relaxation of Muscle spasms - 2. Prevention or retardation of disuse atrophy - 3. Increasing local blood circulation - 4. Muscle re-education - 5. Maintaining or increasing range of motion - 6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For EMG - To determine the activation timing of muscles for: - 1. Retaining of muscle activation - 2. Coordination of muscle activation An indication of the force produced by muscle for control and maintenance of muscle contractions - 1. Relaxation muscle training - 2. Muscle re-education For EMG triggered Stim - 1. Stroke rehab by muscle re-education - 2. Relaxation of muscle spasms - 3. Prevention or retardation of disuse atrophy - 4. Increase local blood circulation - 5. Muscle re-education - 6. Maintaining or increasing range of motion For DC Continuous Mode - Relaxation of muscle spasm 1)

ComboRehab is four channels combination unit, can provide muscle stimulation, ultrasound, biofeedback and combination therapy. This product is designed to offer a multiple choices for clinician in one compact and integrated package. A large control knobs located on the panel, allows clinician very easy to select different therapy mode and set therapeutic parameters. The award winning design offers a 5 inch Touch TFT LCD color display screen that can helps clinician to monitor the treatment information promptly. In the electrotherapy mode, it's freedom for clinician to select one, two, three or four channels into therapy. A comprehensive set of current waveforms is available, targeting both pain management and muscle stimulation applications; interferential (4-pole), premodulated (2-pole interferential), Russian, NMS (Pulsed mode, burst mode), high volt, TENS, Microcurrent and Direct current. The Ultrasound mode can be equipped with two applicators, 1cm² and 5cm². The applicators can operate in continuous or pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz. The EMG mode can provide us detail information about the organ-specific properties of a muscle through surface EMG electrodes. EMG biofeedback activity can couple with triggered electrical muscle stimulation using selected electrotherapy waveforms for the maximum benefit in muscle re-education. The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic. NMS, NMS burst mode, and High Voltage pulsed Current.

Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain relief, 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, chronic pain and joint contractures resulting from: Capsular tightness, Capsular scarring. For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: Symptomatic relief of chronic intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Additionally for EMS, NMS, Hi-Volt and Russian: 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.

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The indications for use of the proposed device are the same as those for the predicate devices. Ultrasound therapy: - 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 pain, muscle spasms and joint contractures resulting from: - Capsular tightness - Capsular scarring Electrotherapy: - Relaxation of muscle spasm - 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 - Symptomatic relief or management of chronic, intractable pain - Post-traumatic acute pain - Post-surgical acute pain

The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module. The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV). The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles. At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms: Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.

MUSCLE STIMULATOR INDICATIONS FOR USE: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining or increasing range of motion Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. ULTRASOUND INDICATIONS FOR USE: Application of deep heat for: 1. Temporary relief of minor pain 2. Muscle spasm relief 3. Joint contracture relief Not for treatment of malignancies. Not for use on the face.

The Futura Pro (US Specification) is a 10 channel Electronic Muscle Stimulator system with a diathermic ultrasound attachment. The main muscle stimulation part consists of a main control unit which powers and controls a separate stimulator that repetitively contracts skeletal muscles by applying transcutaneous electrical pulses to areas of the body that require therapy for the indicated conditions. These pulses for muscle stimulation are applied via self adhesive electrodes applied on the skin. The ultrasound attachment is also powered by the main control unit. The diathermic ultrasound signal is delivered via an acoustic coupling gel. The ultrasound applicator has all the necessary controls (on/off amplitude) in the handset and derives only a time controlled power source from the main control unit. Set programs, with predetermined parameters, are selectable by the operator. On screen instructions guide the user, displaying numbered programs, indication of intensity levels, adjustments, and treatment use. The output leads have indicator LEDs identifying each output as the electrodes are positioned and the intensity adjusted. The system is powered either internally from a 12V rechargeable sealed battery within the main control unit or via an external12VDC power supply. Not part of this submission: Electrodes and Conductive gel. Dr. Wenker shall purchase and distribute the FDA-cleared electrodes and coupling gel, which have been specified by Ultratone Scientific Instruments to ensure proper operation of their equipment. Initially, Ultratone Scientific Instruments has specified electrodes and coupling gel from the respective manufacturers, Axelgaard and Parker. Dr. Wenker shall be purchasing and distributing these two items separately. The stimulator contains safe-start electronic output interlock circuits to ensure stimulation is not suddenly applied to the patient at turn on. The stimulation outputs can subsequently be adjusted by a master output control.

Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as; 1. Relief of pain, muscle spasms and joint contractures: 2. 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. 3. Relief of pain, muscle spasms and joint contractures resulting from: Capsular tightness, Capsular tightening. 4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms: 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain. EMS, TENS, Hi Volt and Russian waveforms: 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis. DC (Direct Current): 1. Relaxation of muscle spasms.

The Sonicator® Plus 920, Model ME 920 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator® Plus 920 provides interferential (4-pole), pre-modulated(2-pole interferential), medium frequency (Russian), EMS, High Volt, TENS, microcurrent and direct current (DC) waveforms with enhanced reliability and ease of use. In addition the Sonicator® Plus 920 offers 1 and 3 MHz ultrasound using dual frequency 5.5 cm2 applicator. An optional 0.9 cm applicator at 1 and 3 MHz is also available. The two-channel Sonicator® Plus 920 allows the clinician to utilize up to two different waveforms using two channels simultaneously. They can choose between several different amplitude modulation options such as the surge, reciprocation and vector sweep The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option. The Sonicator Plus provides both a membrane panel and a touchsensitive screen to allow you to quickly set up treatments. 90 preset treatment setups allow quick set up of a treatment that is already in the memory, plus any of these programs may be customized with the clinician's own treatment protocols. The Sonicator® Plus 920 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, TENS, High Voltage, microcurrent and DC waveforms.

Tone-A-Maticis indicated to be used for L Russian and EMS 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 postsurgical stimulation of calf muscles to prevent venous thrombosis. TENS for: ロ - Symptomatic relief of chronic, intractable pain. - · Management of pain associated with post-traumatic or post-operative conditions.

The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device. The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min. It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.

Therapeutic Ultrasound 1. Pain relief 2. Reduction of muscle spasm 3. Joint contractures Transcutaneous Electrical Nerve Stimulation 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain

The CT2011 SonicStimu Pain Relief Device is comprised of following main components: - A system console including software and control electronics; - A control and display panel; - Device accessories including AC-DC Adaptor, Electrode 40*90mm, Lead for adapter, Lead for electrical. The CT2011 is a single channel combination unit for therapeutic ultrasonic and transcutaneous electrical nerve stimulation. The microprocessor in CT2011 provides pro-modulated low frequency and monophasic electrical pulse waveforms with enhanced reliability and ease of using of the device. In the same time it offers I MHz ultrasound treatment also. The user interface friendly comprises keys, LCD and audio feedback. The LCD provides operator information about operation mode and signal intensities. The user through control buttons to make adjusting power for ultrasound and stimulation. The CT2011 can be used as electrical stimulation or ultrasound therapeutic equipment separately or combination for both.

Therapeutic Ultrasound: 1. Relief of pain, muscle spasms and joint contractures: 2. 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 3. Relief of pain, muscle spasms and joint contractures resulting from: - Capsular tightness - Capsular tightening 4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms: 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain EMS, TENS, Hi Volt and Russian waveforms: 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis DC (Direct Current): Relaxation of muscle spasms

The Sonicator® Plus 940 , Model ME 940 is a four-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 940 provides premodulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 940 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators. The four-channel Sonicator Plus 940 allows the clinician to utilize up to two different waveforms using four channels simultaneously. The clinician can choose between several different amplitude modulation options such as the surge, reciprocation and amplitude modulation (interferential only, vector rotation). The interferential and premodulated modes offer frequency modulation as well as a static frequency option. The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine. Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. A large LCD output display allows the clinician to monitor four channels simultaneously for four channel combination treatment protocols. It also allows the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current. The Sonicator Plus 940 can provide electrical stimulation only. ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms