Search Results

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.

The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a disposable hydrogel electrode patch, an external pulse transmitter, an external pulse transmitter stimulation tester and a device used by the patient to wirelessly control the external pulse transmitter. The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. The complete StimRouter System consists of three kits: a Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the external pulse transmitter which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation. The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle, and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead. The Clinician Kit is used for the programming of the external pulse transmitter. The components of the Clinician Kit are a tablet PC with programming software that is capable of connecting to and configuring the external pulse transmitter. The User Kit contains the patient-use components of the StimRouter System. The components are the External Electric Field Conductor (E-EFC), an external pulse transmitter, with included charger and the StimRouter Electrode Carrying Case. After the E-EFC is programmed, the E-EFC can be connected to the StimRouter Electrode through which it can deliver stimulation transcutaneously to the implanted lead receiver.

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.

The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories. Accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT). The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. Only the Procedure Manual has been modified to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated. The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation. The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead. The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT. The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.

The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait. The L100 Go System may also: - · Facilitate muscle re-education - · Prevent/retard disuse atrophy - · Maintain or increase joint range of motion - · Increase local blood flow

The L100 Go System is designed to improve gait in adults suffering from foot drop or muscle weakness. The L100 Go System can also deliver transcutaneous stimulation to the muscles in the lower leg to facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and/or increase local blood flow. The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff: - 1) External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events. - 2) Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go. - 3) Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient. - 4) Power supply (charger) with two USB ports and a proprietary cable to charge the EPG. - 5) Tester, which is used for trouble shooting to confirm that stimulation is being delivered. - 6) Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity. - 7) Electrode and electrode bases which are attached to the inner side of the lower leg cuff. The L100 Go System can be operated in one of the following modes: - Gait Mode - Training Mode • - . Clinician Mode Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

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.

The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT). The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region. The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation. The Lead and lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead. The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT. The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.

The L360 Thigh System is intended 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait. The L360 Thigh System may also: - Facilitate muscle re-education - Prevent/retard disuse atrophy - Maintain or increase joint range of motion - Increase local blood flow - Provide early post-surgical quadricep and hamstring strengthening - Improve post-surgical knee stability secondary to quadricep and hamstring strengthening - Relax muscle spasms

The L360 Thigh System is intended to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damaqe to pathways to the spinal cord). The L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual's gait. The L360 Thigh System consists of: - 1. One or two Thigh Functional Stimulation Cuffs (Thigh Cuff) that include surface electrodes. - 2. Central External Pulse Generator (EPG). The EPG delivers stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. The EPG can use motion sensor based algorithm to detect heel events. - 3. An optional Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status. - 4. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. - 5. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient. - 6. An optional Mobile Application (MAPP) enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity. - 7. A power supply with two USB outputs and a proprietary cable to charge the EPG(s).

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 foot and/or knee flexion or extension: thus, it also may improve the individual's gait. The L300 Go System may also: - o Facilitate muscle re-education - o Prevent/retard disuse atrophy - o Maintain or increase joint range of motion o Increase local blood flow

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 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) such as selecting mode of operation (gait/training) or fine-tune the stimulation intensity for each EPG individually. - 8) Optional Foot Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. - 9) Optional Mobile Application (MAPP), which can be downloaded on a smartphone and offers the same control functions as the optional Control Unit, as well as enabling the patients to retrieve and monitor their daily activity. At the time of clearance of K173682, the MAPP was only an iOS-based application. In this submission, Bioness is adding an Android-based MAPP. The software features, user interface, and wireless communication protocol of the Android version are the same as the iOS version, the only difference is the operating system. The L300 Go System can be operated in one of the following modes: - Gait Mode - Training Mode ● - . Cycle Training Mode - . Clinician Mode Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Cycle Training Mode is used to train muscles while the patient is using a stationary exercise bicycle, and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

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, 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 qait. The L300 Go System consists of: - 1. One or two Functional Stimulation Cuffs (L300 Lower Leg and Thigh), that include surface electrodes. - 2. External Pulse Generator (EPG) for the lower leg and EPG for thigh. Both EPG's deliver stimulation to their respective cuffs, and have user interface, including visual, audio, and tactile feedback. Lower EPG can use motion sensor based algorithm to detect heel events. - 3. A Control Unit that allows simple wireless remote control of the EPG's while displaying real-time information regarding the system's status. - 4. An optional Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. - 5. A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient. - 6. A power supply with two USB outputs and a proprietary cable to charge the EPG.

The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus System may also: - Facilitate Muscle re-education - Prevent/retard disuse atrophy - Maintain or increase joint range of motion - Increase local blood flow

The NESS L300 Plus System is intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. The NESS L300 Plus System is a combination of its two predicate devices of its two predicate devices, the NESS L300 (K080219) and the NESS System (K022776). The NESS L300 Plus System consists of: - A Control Unit that allows simple operation while displaying real time information regarding the system's status. - Two Functional Stimulation Cuffs (L300 and Thigh, figures 11-2, 11-3 respectively), that include two surface electrodes and an integrated configurable Radio Frequency Stimulation unit each. - A Gait Sensor, which uses a dynamic gait tracking algorithm to detect heel events and wirelessly synchronizes stimulation. - A Clinician's Programming System with software, which is used for system programming by a trained clinician during configuration of the system for optimal fitting to the patient. - A L300 Tester. The L300 Tester is utilized for checking the RFSs and FSCs for functionality. - A power supply with a 3-way splitter cable to charge the Control Unit and both Radio Frequency Stimulation units.