Search Results

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric 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 L300 Go 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 L300 Go System may also: - Facilitate muscle re-education - · Prevent/retard disuse atrophy - · Maintain or increase joint range of motion - · Increase local blood flow

The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord injury) or other disability. The L300 Go System 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 L300 Go system consists of the following components: - 1) External Pulse Generator (EPG), which can be plugged into lower leg Functional Stimulation Cuff (FSC) or thigh FSC or into both cuffs. EPG contain user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events. - 2) Lower leg FSC, including cradle for the EPG. - 3) Upper leg FSC, including cradle for the EPG. - 4) Clinician Application (CAPP), based on tablet PC. CAPP will be used by a trained clinician during configuration of the system for optimal fitting to the patient. - 5) Power supply (charger) with two USB ports and a proprietary cable to charge the EPG. - 6) L300 Go Tester. - 7) Optional Control Unit that allows simple control of the EPG(s). - 8) Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. - 9) Optional Mobile Application (MAPP), based on the SmartPhone platform enabling the patients to wirelessly retrieve and monitor their daily activity. At the time of clearance of K162407, the MAPP did not include any control feature, but control features like those of the Optional Control Unit have been added to the MAPP and are part of this submission.

The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Not Found

The NESS H200® Wireless Hand Rehabilitation System 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 range of motion - - Prevention and/or retardation of disuse atrophy l - Increase of local blood circulation - - Reduction of muscle spasm — - Muscle re-education | The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless System. The Intelli-Connect is used to trigger the H200 Wireless Orthosis through simple jaw movements.

The NESS H200 System consists of the following components: - Functional Stimulation (FS) Orthosis with a Radio Frequency (RF) Stim Unit . - Control Unit . - . Intelli-Connect triggering device optional accessory, consisting of an earpiece, a charger and connecting cable The Intelli-Connect Earpiece triggering device is fitted over the ear and detects clicks of the teeth to wirelessly trigger the stimulation unit of the H200 Wireless orthosis. Software built into the Intelli-Connect earpiece is designed to register and work exclusively with the patient's orthosis. The Earpiece is rechargeable with a lithium-polymer battery. It is FCC identified and meets part 15 of the FCC regulations. Once the earpiece is turned on, Intelli-Connect will trigger stimulation when teeth are clicked together.

The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

The L300 Foot Drop System consists of Control Unit and Intelli-Sense Gait Sensor.