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The Synchrony (20-3000) is an electrical stimulation device indicated for the following uses: **Functional Electrical Stimulation (FES).** - Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. **NeuroMuscular Electrical Stimulation (NMES).** - Maintenance and/or increase of hand range of motion. - Prevention and/or retardation of disuse atrophy. - Increase in local blood circulation. - Reduction of muscle spasm. - Re-education of muscles.

The Synchrony (20-3000) system is a functional electrical stimulation (FES) device and a powered muscle stimulator. It is specifically designed to enhance hand functionality in patients with arm paresis through a range of customizable therapies. The system integrates five major components: the Stimulator, Sensor, Patient Interface (electrodes), Motor Point Probe, and Clinician App. The therapies are directed and programmed by a clinician through an iOS based application and then the patient may apply the therapy at their home with the Stimulator and Sensor. The Synchrony system supports three primary therapeutic modes: Contralaterally Controlled Electrical Stimulation (CCFES), cyclical Neuromuscular Electrical Stimulation (CNMES), and Functional Task Practice (FTP). The CCFES mode uses sensor data from the patient's unimpaired side to control the timing, intensity, and movement of the paretic hand/arm, synchronizing stimulation with natural motor patterns. The cyclical NMES mode delivers repetitive stimulation to targeted muscles, aiding in muscle re-training, as described in the systematic review of research studies using cyclic NMES. The FTP mode allows for direct control of hand movements during task-oriented exercises, using real-time sensor feedback and stimulator output. Stimulation is delivered through up to four electrodes placed on identified motor points, using symmetric balanced biphasic pulses. The system offers preset stimulation amplitudes of 20mA, 40mA, and 60mA, with a pulse width adjustable between 1-250 µsec, providing high precision with 1 µsec resolution. The device's enclosure is constructed from biocompatible ABS Cycoloy, ensuring durability and patient safety, and is rated IP22 for ingress protection. The stimulator can operate independently or in conjunction with the Synchrony Sensor, depending on the therapy mode selected. The Sensor, which communicates wirelessly with the Stimulator via Bluetooth Low Energy (BLE), uses a Class I laser that is compliant with 21 CFR 1040.10 and 21 CFR 1040.11 to measure hand opening and closure distances, enabling accurate therapeutic adjustments. Both the Stimulator and Sensor are wirelessly charged using an FCC Part 15 compliant charging pad, enhancing ease of use and handling. The Synchrony system is engineered for ease of use with user-friendly control interfaces for both patients and clinicians. It incorporates a range of safety mechanisms to ensure effective and safe operation, making it a versatile and reliable tool for improving hand functionality through personalized therapeutic interventions.

The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The Cionic Neural Sleeve NS-200 may also: - Facilitate muscle re-education - Prevent/retard disuse atrophy - Maintain or increase joint range of motion - Increase local blood flow As a powered muscle stimulator the Cionic Neural Sleeve NS-200 is indicated for the following conditions: - Relaxation of muscle spasm As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions: - Biofeedback, relaxation and muscle re-education purposes

Same as the primary predicate device, the Cionic Neural Sleeve NS-100 (K221823), the Cionic Neural Sleeve NS-200 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-200 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance. The Cionic Neural Sleeve NS-200 system sales carton consists of the following components: 1) SL-200 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in four sizes: extra-small, small, medium, and large. 2) DC-200 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-200. The DC-200 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app"). 3) Power supply and cable to recharge the DC-200 and connect the DC-200 to a user's computer when required. 4) Adhesive, electrically conductive and replaceable electrode pads. 5) Electrode cover sheets. 6) Instructions for Use documents. Components are available as accessories to the Cionic Neural Sleeve NS-200 system: - Replacement electrode pads. The Cionic Neural Sleeve NS-200 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-200 iOS and Android users. The Cionic Neural Sleeve NS-200 system consists of a software and hardware architecture that enables users to access a library exercise and programs. Programs can be added and removed from the user's mobile app by the user. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs. The following minor hardware/mechanical changes have been made to the NS-100 (K221823) and incorporate in the NS-200: 1. Simplified Sleeve Electronics By relocating the electromyography (EMG) circuitry to the Control Unit (DC-200), the redesigned Sleeve (SL-200) is now lighter, more streamlined, and requires less power—delivering a more comfortable and efficient experience for users. 2. Enhanced Control Unit Grip The Control Unit (DC-200) now features integrated side grips, making it easier to connect and disconnect from the sleeve cable—while maintaining the same compact form factor users love. 3. More Secure Fit, All Day Comfort Enhanced Velcro sections on the Sleeve (SL-200) offer improved adherence and a more secure fit, supporting confident wear and optimal electrode positioning throughout the day.

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.

The NeuStim NN-01 is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES): Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES): - · Maintaining or increasing hand range of motion; - · Prevention or retardation of disuse atrophy; - · Increasing local blood circulation; - · Relaxation of muscle spasms; and - · Muscle re-education. The NeuStim NN-01 is intended for use on the right arm/right hand only.

The NeuStim Model NN-01 (herein Device) consists of a voltage-controlled generating source that connects to disposable electrodes that are worn by the patient on the anterior and posterior forearm and around the thumb, these are named the Flexor, Extensor and Thumb Disposable Electrodes respectively. The disposable electrodes consist of multiple contacts that can stimulate the muscles in different areas of the forearm and thumb with 10kHz voltage pulses generated by the NeuStim voltage-controlled stimulator. The Device is classified as a Functional Stimulation (FES) and NeuroMuscular Electrical Stimulation (NMES) device. The Device uses galvanic electrical energy to evoke muscle contractions. The Device has 181 addressable electrode contacts enabling fine spatial resolution of stimulation to the patient. The Device allows manual electrode scanning to facilitate rapid mapping of effective stimulation points, which can be stored for use in future sessions. This rapid scanning capability is enabled through the use of solid-state relay technology embedded in the flexible patches that mate directly with the disposable electrodes. The motion of the user's (i.e. licensed healthcare professional) finger on the screen of the NeuStim" Tablet electronically steers the stimulation point through the use of a solid-state relay matrix in each patch and thumb dongle, while lighting LED indicators on the back of the patch/dongle under control. This allows immediate, dynamic visual indication of the stimulation location which facilitates rapid mapping (i.e. user can quickly find and return to useful stimulation points). When the user observes desired muscle activations and associated wrist, hand, or finger movements, the related stimulation locations can be stored as a pattern. Up to three of these stored patterns can then be combined into a compound move where the stimulator will continuously time multiplex between them to allow for compound motion. Finally, up to three compound moves or patterns can be combined into a sequence where each of the selected compound moves or patterns are applied for a user configurable number of seconds. The Device uses a stimulation pulse repetition rate of 50 Hz. The stimulation pulse is comprised of a multiphasic (5 cycle) waveform with a total duration of 0.5 ms. The stimulation output (peak) voltage is less than 65V (500 Ohm load) and less than 120V (10,000 Ohm load). The stimulation output power will not exceed 0.25 W/cm^2 (averaged over one second) into a 500 Ohm Load.

MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses: Functional electrical stimulation (FES) Improvement of arm and hand function and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) for general rehabilitation for: - · maintenance and/or increase of arm and hand range of motion, - · prevention and/or retardation of disuse atrophy, - · increase in local blood circulation, - · reduction in muscle spasm, and - · re-education of muscles. MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove 2.0 Systems.

The MyndMove and MyndMove 2.0 Systems are neuromodulation devices that deliver short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove and MyndMove 2.0 systems comprise the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The Functional Electrical Stimulators in the MyndMove 2.0 are eight-channel devices with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided. Each MyndMove/MyndMove 2.0 Stimulator is connected, via an IEEE 802.11 a/b/g/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove 2.0 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove and MyndMove 2.0 use surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand. MyndMove and MyndMove 2.0 are based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove or MyndMove 2.0 protocols achieve a wide range of functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the MyndMove/MyndMove 2,0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting a movement. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.

The EvoWalk 1.0 System is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stoke, damage to pathways to the spinal cord). The EvoWalk 1.0 System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension; thus, it also may improve the individual's gait.

The EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion in adult individuals with muscle weakness related to upper motor neuron diseaselinjury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings. The EvoWalk 1.0 system consists of the EvoWalk device with an elastic band and built-in rechargeable lithium polymer battery, and the accessories including the EvoWalk mobile application, micro USB type charge cable with charge port, lead cables (one single channel and one dual channel), eight sets of electrodes for each channel, instructions for use (IFU), and a carrying case.

The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease /injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The Cionic Neural Sleeve NS-100 may also: - Facilitate muscle re-education - Prevent/retard disuse atrophy - Maintain or increase joint range of motion - Increase local blood flow

The Cionic Neural Sleeve NS-100 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-100 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance. The Cionic Neural Sleeve NS-100 system sales carton consists of the following components: - 1) SL-100 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in two sizes: small, and medium. - 2) DC-100 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-100. The DC-100 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app"). - 3) Power supply and cable to recharge the DC-100 and connect the DC-100 to a user's computer when required. - 4) Adhesive, electrically conductive and replaceable electrode pads. - 5) Electrode cover sheets. - 6) Instructions for Use documents. Components are available as accessories to the Cionic Neural Sleeve NS-100 system: - o Replacement electrode pads. The Cionic Neural Sleeve NS-100 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-100 iOS and Android users. The Cionic Neural Sleeve NS-100 system consists of a software and hardware architecture that enables users to access a library exercise and augmentation programs. Programs can be added and removed from the user's mobile app. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.

MYNDMOVE is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES) Improvement of ann and hand functions and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) · Maintenance and/or increase of arm and hand range of motion - · Prevention and/or retardation of disuse atrophy - · Increase in local blood circulation - · Reduction of muscle spasm · Re-education of muscles. Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.

The MyndMove 2.0 System is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove system comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The MyndMove 2.0 Functional Electrical Stimulator is an eight-channel device with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided. Each MyndMove Stimulator is connected, via an IEEE 802.11 a/b/q/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove 2.0 Therapy can only be administered by trained MyndMove Therapy professionals (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove system. MyndMove 2.0 uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand. MyndMove 2.0 is based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove 2.0 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove 2.0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting move and as the arm and/or hand is moved into the instructed position. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.

NMES 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 EMG Triggered Stimulation (ETS) (nonimplanted electrical continence device only) Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detrusor muscles through reflexive mechanisms of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal) TENS Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain EMG Biofeedback, relaxation muscle training and muscle re-education

Levator Elite(Model LE9011) is a single channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The device contains EMG biofeedback, TENS (Transcutaneous Electrical Nerve Stimulation), ETS (EMG triggered stimulation) and NMES (Neuromuscular Electrical Stimulator). Each of them has pre-set and custom programs. The parameters of the device are controlled by the buttons, the levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers. The device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrode pads applied on the skin or through a vaginal probe/rectal probe (for incontinence treatment protocols only). It can be used with or without linkage to a PC. Connecting the device with the PC via USB cable, the data can be transmitted between PC and device (It needs purchase the PC software Nu-Tek System and USB connection cable). For EMG biofeedback, EMG is for detecting the signal of muscle, which display muscle strength via EMG biofeedback bar graph or waveform format viewed on the LCD screen of the unit. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity. For NMES is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilization, selective muscle retraining. For ETS (i.e. EMG triggered stimulation), ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes, vaginal probe or rectal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance. For TENS, the device provides a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions: it only helps to control the pain perception. LE9011 consists of the following elements: - Main device - Pedestal - Lead wire - Electrode pad - Vaginal probe - Rectal probe (optional) - PC Software(optional) - USB Cable(optional)

The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease /injury (e.g. stroke, damage to the spinal cord). The Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The Cionic Neural Sleeve NS-100 may also: - Facilitate muscle re-education - Prevent/retard disuse atrophy - Maintain or increase joint range of motion - Increase local blood flow

The Cionic Neural Sleeve NS-100 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-100 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance. The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The Cionic Neural Sleeve NS-100 system sales carton consists of the following components: - 1) SL-100 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in two sizes: small, and medium. - 2) DC-100 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-100. The DC-100 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app"). - 3) Power supply and cable to recharge the DC-100 and connect the DC-100 to a user's computer when required. - 4) Adhesive, electrically conductive and replaceable electrode pads. - 5) Electrode cover sheets. - 6) Instructions for Use documents. Components are available as accessories to the Cionic Neural Sleeve NS-100 system: - Replacement electrode pads. The Cionic Neural Sleeve NS-100 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-100 users. The Cionic Neural Sleeve NS-100 system consists of a software and hardware architecture that enables users to access a library exercise and augmentation programs. Programs can be added and removed from the user's mobile app. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.