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The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator. Motive Electrode is intended for adults of 22 years of age and older.

The Motive Electrode provides an electrically conductive interface between a neuromuscular electrical stimulator (muscle stimulator) and a user's skin. The Motive Electrode is provided nonsterile, is designed and intended for single patient use only, multiple application use, and is disposable. The electrode sheet is to be worn on the thigh covering the quadriceps muscles to apply electrical stimulation therapy when connected to a muscle stimulator. The electrodes are conductive pads that contact the skin. The electrical stimulation impulses are delivered through the electrodes on the skin in direct proximity to the muscles to be stimulated. The Motive Electrode consists of multiple layers. The skin-contacting layer of the electrode sheet is comprised of three separate medical grade, self-adhering, biocompatible, and conductive hydrogel (gel) pads. These gel pads are placed on a single polyester or polyethylene terephthalate (PET) sheet. These gel pads include two rectangular 2 inch x 4 inch (5.1 x 10.2 cm) and one circular. 2.165 inch diameter (5.5 cm) pads. The outermost layer of the electrode contains a magnetic connector housing for electrical connection to the muscle stimulator. Silver ink printed conductive electrical traces on the PET film are utilized to provide electrical conductivity from the muscle stimulator to the gel pads. When not in use, the electrode sheet is covered by a paper-backed release liner.

The Motive™ Knee Wrap device is intended to strengthen the quadriceps muscle stimulation to provide symptomatic temporary pain relief associated with knee arthritis. The Motive™ Knee Wrap device is indicated for adults of 22 years of age and older.

The Motive Knee Wrap device (Motive device) is an over-the-counter (OTC) electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) for relief of knee pain associated with knee arthritis. The Motive device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with arthritis. The stimulator continuously contracts quadricep muscle groups for strengthening of the muscles and knee pain relief. The stimulator is placed over the thigh muscle and just above the knee.

The Intellihab system is intended to strengthen the quadricep muscle stimulation to provide symptomatic temporary pain relief associated with knee osteoarthritis and improvement of the knee joint mobility when the recommended treatment regimens are followed. In addition, the Intellihab System is indicated for the following: - Retardation or prevention of disuse atrophy - Evaluation of joint mobility by measuring and recording range of motion . The Intellihab System is indicated for adults of 22 years of age and older.

Intellihab System is a remote monitoring electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements. Intellihab device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with osteoarthritis. The stimulator is intended for medical purposes that continuously contracts muscle groups for an intended therapeutic application and allows for remote monitoring of therapeutic data by the healthcare Providers. The stimulator is provided with an integrated battery powered digital goniometer that allows for measurement of knee joint range of motion. The stimulator along with the digital goniometer is placed over or in proximity to affected joint. The Intellihab System includes a provider portal allowing for remote monitoring of collected patient data through Intellihab mobile app and API interface.

The CyMedica e-vive System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). Indications for Use: - As an NMES device, indications are for the following conditions: - Relaxation of muscle spasms - Retardation or prevention of disuse atrophy - Increasing local blood circulation - Re-educating muscles - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain

The CyMedica e-vive™ System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The e-vive™ system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways. The e-vive device is equipped with a goniometer (Class I, 510(k) Exempt), which is intended to measure and record joint range of motion. e-vive™ electrical stimulation technology is based on the electrical stimulation technology developed for CyMedica QB1™ system. K150413. The e-vive™ electrotherapy programs are delivered to the patient directly by a User Interface controller integrated in a conductive garment. The stimulation programs are managed wirelessly using a mobile application developed for use on smart phones or tablets that interact with the User Interface controller. The e-vive™ system are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment. In NMES mode, the e-vive™ system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The evive™ NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas. In NMES mode, the e-vive™ system consists of a knee conductive garment with an incorporated Controller, docking receptacle, range of motion sensor, three electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device. As a TENS device, the e-vive TENS treatment is a safe and effective method of providing a drug-free method of pain relief. Patients with recurring pain, can utilize the e-vive TENS treatment program for immediate and long-term pain relief. The e-vive™ TENS system consists of a conductive garment with an incorporated Controller. docking receptacle, two electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device. The e-vive electrogoniometer (battery powered goniometer) is capable of measuring and recording the joint range of motion by using two sensors to detect the knee range of motion. One sensor is located on the Controller board and the second sensor is located within the sensor pod, on a small electronic board. The sensor pod is contained within the conductive garment below the knee area opening. The sensor pod is connected wirelessly to the Controller using a BLE connection. The sensor data from the sensor pod and the Controller sensor is conveyed to the mobile device real time. The sensors can detect the knee extension/flexion angles, and associated range of motion angle through the use of the e-vive mobile app when initiated by the patient or healthcare provider. The e-vive™ System incorporates a Bluetooth Low Energy, BLE 4.1 connection module to enable wireless communication and can be paired with a Bluetooth enabled mobile device running the e-vive™ App, available from the App stores. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user. The Controller is connected to the conductive garment via a 16-pin interface. The Controller contains the primary safety controls for operation of the device and a push button is available for switching the unit on or off. The power button remains active and can be used in the event of loss of Bluetooth connection to power on/off the device or start/stop stimulation while performing stimulation sessions. The e-vive™ system contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and Bluetooth™ activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). Indications for Use: As an NMES device, indications are for the following conditions: - Relaxation of muscle spasms - Retardation or prevention of disuse atrophy - Increasing local blood circulation - Re-educating muscles - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain

The CyMedica Orthopedics QB1 System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The QB1 system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways. The OB1 NMES and TENS systems are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment. In NMES mode, the QB1 system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The OB1 NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas. In NMES mode, the OB1 system consists of a Conductive garment with an incorporated NMES pod, User Interface device with a battery charger, NMES electrodes, and electrode gel. The QB1 device also offers a TENS program for pain management. The QB1 TENS system consists of a TENS pod. User Interface device with a battery charger. TENS electrodes, and electrode gel. The QB1 User Interface is programmed with an embedded software to manage the treatment programs and communicate with the User Interface touchscreen, NMES conductive garment, and TENS pod. The User Interface allows the user to select a treatment from the available treatment programs stored in the memory component of the NMES conductive garment and TENS pod. The User Interface utilizes a touchscreen and tactile buttons for user control. The User Interface device is powered by an internal rechargeable 3.7 V Lithium Ion battery that, when fully charged, can deliver at least three-20 minute treatments before requiring a recharge. The QB1 USB charger can fully recharge the battery in approximately five hours. The QB1 system accessories include: - . OB1 electrodes for NMES application - OB1 electrodes for TENS application - QB1 electrode gel ●