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The PTG-05 is intended for: - Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. - Strengthening, toning and firming of buttocks & thighs. - Strengthening, toning and firming of arms

The PTG-05 is a non-invasive therapeutic device. The device produces an electrical current that interacts with the tissues of the human body. The PTG-05 is intended to increase the musculature of the abdominals, buttocks, arms and thighs. The device is intended to be used with single-use electrodes from Zimmer MedizinSysteme GmbH (K140340) or equivalent. The output of biphasic and middle frequency currents for muscle stimulation with maximum 8 channels at a time allows to treat several treatment areas simultaneously. For an efficient treatment the user is guided via user interface throughout the whole treatment. First, the user can select the treatment area with the device illustrating where to place the electrodes. The modules are automatically matched to the specific treatment area while highlighted in the color of the matching trunk cable of the module. In the therapy screen, the user can select one of the 5 pre-set treatment protocols for each treatment region based on the training level of the patient. During the treatment, an animation of the electrodes is shown in the screen that outlines if the protocol is in a "work-phase" which means a contraction phase or if the protocol is in a "relax-phase" which refers to a muscle relax phase. Expert mode In addition, all 4 modules can be split into 8 channels using "Expert mode" for a precise adjustment of the individual channels. This is ideal to set different intensities for the inner musculature than for the outer musculature of a specific treatment area, for example. Link-mode All of the modules can be linked together which enables the use of the remote control where the patient by itself can set the intensity and stop the therapy at any time.

The RFG-01 is intended to: - provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - provide, with a massage device, a temporary reduction in the appearance of cellulite.

The RFG-01 is a mobile standalone equipment with four wheels and consists of a console (main unit), a color display with touch operation and three handpieces (small, medium, and large). The device develops localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. The purpose of the treatment based on the radiofrequency system is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The devices use RF electrodes of the resistive (or bipolar) types. Resistive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts. The use of different sizes allows efficient and effective treatment of various parts of the body. Two of the three handpieces can be used with or without vacuum, allowing an even deeper application of heat. The handpieces are to be used with a small amount of contact lotion, the purpose of which is to assist in heat transfer. The LEDs on every handpiece indicate the coupling and the correct temperature range during the treatment. The color touchscreen displays all treatment-related parameters.

MFG-05 is intended to provide entirely non-invasive electromagnetic stimulation of the pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

The MFG-05 is a non-invasive therapeutic device produces a magnetic field that interacts with the tissues of the human body. By stimulation of the pelvic floor musculature, the MFG-05 helps to treat of male and female urinary incontinence. The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. One applicator is available for therapy and is positioned centrally under the pelvic floor of the patient while the patient is wearing sport pants or any other pants without metallic parts. The device is for prescription use and used by a trained medical professional in a professional healthcare facility. The main body of MFG-05 is used to control the function of magnetic stimulation. It is operated with parameters such as frequency, time and intensity. These parameters can be controlled by the user on screen display and with the help of a rotary knob at the user control panel.

The ThermoTK device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The ThermoTK massage device is intended to provide a temporary reduction in the appearance of cellulite.

ThermoTK is a medical diathermy device for external tissue heating on the human skin with the purpose of increasing tissue temperature by applying electromagnetic fields of 460 or 540 KHz. The device includes a plastic housing with a capacitive touch display which guarantees an easy handling to select and start a treatment. In this housing, an electronic power module is implemented which drives the electromagnetic energy into the connected handpiece. By using the two adjusters, it is possible to set the treatment intensity and treatment time. Two handpieces for two different treatment modes are attached and can be connected to the control unit depending on which treatment mode the therapy has to be performed. An electrode (resistive or capacitive) has to be plugged on the handpiece for treatment. The device also includes two different electrode cables which can be connected with attached common electrodes (self-adhesive or reusable). For a better stability while using the handpiece during application, a silicone spacer can be put between handpiece and electrode.

clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

The clTrac is powered traction equipment that offers both static and intermittent traction. Spinal traction is a form of decompression that relieves the pressure on the spine. Traction is a non-surgical, non-invasive and non-pharmaceutical treatment for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The clTrac is intended to be used by healthcare professionals (HCP) on their patients. When device is operational, the applied force shall not exceed +/-10% of the target force as set by the operator. clTrac applies a specific force onto the traction cord. The applied force is set by the operator by means of the touch screen and rotary knob. A patient interrupt button is available for the patient to pause the therapy. The cl Trac is a non-invasive therapeutic device. The device consists of a console with ABS housing. The console consists of an aluminium ground plate, an ABS outer shell, a 7" touch screen and a steel central control knob. A 2.9m long cord with a plastic patient interrupt button is plugged into the console. The console is intended to be fastened to a standardized traction table using screws that are tightly screwed into its aluminium ground plate, with holes in a standardized pattern. The implemented motor-gear unit applies traction via a traction cord that is fixed into the console with a 360° swivel head with guide pulley. The traction cord is intended to be attached to hip and thoracic traction belts that are sold separately.

CoolTone is indicated to be used for: - Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen. - Strengthening, toning and firming of buttocks and thighs.

The CoolTone system is a non-invasive, therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the CoolTone helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device is a mobile, standalone unit with four wheels and the control unit housing protects the patient from electrical shock and mechanical injury. Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. CoolTone is a medical device that generates a magnetic field by applying a strong current to an applicator. It is equipped with the securement system, designed to maintain the position of the applicator throughout treatment. A large color touch screen facilitates the use of the device. The on-screen information guides the user, step-by-step, through the entire treatment process. The treatment is operated through variable parameters such as frequency, time and intensity. Three, pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.

The Cryo 7 is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

The Cryo 7 is a non-invasive Therapeutic device. The cold air therapy device cools and dehumidifies the air, which can be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. The cold air therapy device is intended to cool the patient's skin locally and is intended to be used contactless. The subject Cryo 7 device is the same as the currently-cleared Cryo 6 (K060395), except for branding and state-of-the-art updates. Both the subject device and predicate device are manufactured by Zimmer MedizinSysteme GmbH. The mechanical assembling consists of a housing, a chassis with 4 rotating rollers and a shelf plate. The chassis includes all technical components, like compressor, evaporator, condenser, fans and all electrical power components. On the upper front cover, the user interface control it operated via touchscreen. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. The user interface can be controlled via capacitive touch display. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.

The emField is indicated to be used for: *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; and *Maintaining or increasing range of motion.

emField is a non-invasive therapeutic device. The device produces a magnetic field that interacts with the tissues of the human body. By muscle stimulation, the emField is indicated for bulk muscle excitation in the legs or arms for rehabilitative purposes. The device housing protects the patient from electrical shock and mechanical injuries. The device is mobile standalone equipment with four wheels. Two applicators are available for therapy: a large and a small one. The main body of emField is used to control function of magnetic stimulation. It is operated with parameters such as Frequency, Time and Intensity. These parameters can be controlled by the user on LCD and with the help of a rotary knob at the user control panel.

CoolTone is indicated to be used for: • Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen. • Strengthening, Toning and Firming of buttocks and thighs.

The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the CoolTone helps to strengthen, tone and firm abdomen, buttocks and thighs. The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels. Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. The CoolTone is equipped with the securement system which is designed to maintain applicator position throughout treatment. A large color touch screen facilitates the use of the device. The on-screen information guides the user step-by-step through the entire treatment process. The treatment is operated through parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.