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STIM: Electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in adult women. EMG: Relaxation muscle training and muscle re-education. ETS: Treatment of stress, urge or mixed urinary incontinence by assessing EMG activity of the pelvic floor and strengthening pelvic floor muscles using electrical stimulation. This device is intended to be used by adult women (aged above 22 years).

The NeuroTrac® MyoPlus Pro is a single-channel pelvic floor muscle stimulator (STIM) designed to assist patients with urinary incontinence to increase muscle control and overcome pelvic muscle dysfunction. It can also act as an electromyograph (EMG) and features an EMG-triggered stimulation (ETS) mode. The stimulation waveform is symmetrical, rectangular and biphasic. Stimulation is delivered using a vaginal probe. The vaginal probe included with the subject device was cleared under K122194. The subject device may either be operated directly by the prescribing physician, or by the patient as instructed by the physician.

The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women. The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.

The device is intended to provide entirely non-invasive electromagnetic stimulation of 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 BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only. The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments. The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.

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.

Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

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Fotona StarFormer is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the seat of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current which causes muscle contraction in the entire pelvic floor area, increasing the strength and endurance of the pelvic floor. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply and a chair.

The Konmed Incontinence Stimulation Electrode include Vaginal Probe KM-504, KM-505, KM-506, KM-507, KM-5013 & Rectal Probe KM-502. KM-5018 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

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Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Levina Incontinence Stimulation Electrodes are used to treat incontinence when paired with compatible, FDA-cleared electrical stimulators. The probes are intended to provide electrical stimulation to pelvic musculature and for the purpose of rehabilitation of pelvic floor muscles and restoration of neuromuscular control during treatment. The probes come in different models and are available for both vaginal and rectal insertion. The probes are used directly by the patients for home care and are for single-patient, repeat-use. The device comes non-sterile and should be cleaned before and after each use with water and mild soap or neutral detergent.

Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.

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.