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The Shoulder PacemakerTM electrotherapy device is intended for neuromuscular electrical stimulation (NMES). The Indications for Use for the Shoulder PacemakerTM device are: - Prevention or retardation of disuse atrophy; - Muscle re-education; - Maintaining or increasing range of motion. The device is intended for adults and adolescents age 14 and older.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies. The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies. The subject device can be used in stand-alone mode or in wireless mode. The Shoulder Pacemaker should be used in combination with: - conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation; - saver protection, interposed between the stimulator and the patient's arm. - The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation. The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

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.

Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES). The Indications for Use for Shoulder PacemakerTM are: - Prevention or retardation of disuse atrophy; - Muscle re-education; - Maintaining or increasing range of motion. The device is intended for adults only.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies. The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies. The subject device can be used in stand-alone mode or in wireless mode. The Shoulder Pacemaker should be used in combination with: - conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation; - saver protection, interposed between the stimulator and the patient's arm. The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation. The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

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.

ViMove2 is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity. Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values. ViMove2 is comprised of the following key components: - · 4 Wireless Sensors (2 movement and 2 muscle activity) - · Disposable Application Pads for attaching sensors to the patient. - · ViMove software package

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.

Continuous real-time measurement of range of motion.

The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion. The measuring device consists of a monitor central processing unit (CPU), the power supply, and an infrared interface for data transfer. The device is connected to eight sensors via cables. Each sensor is directly attached to the skin with an adhesive pad.

The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis. The Ortelius 800 may be used in medical clinics/institutes.

The Ortelius 800 is a device designed for the measuring and monitoring spine deformities. The Ortelius 800 enables the following features: - · Spine curve reconstruction based on the points sampled by the Sensor. - · Automatically calculated spine deformity angles of the primary curve. - · Indication of the extreme vertebra from which the spine deformity angle was calculated.

The 3 Channel Knee Electronic Amplified Stethoscope is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint.

The device is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint. The 3 Channel Knee Stethoscope System consists of three transducers, or sensors, to pick up the vibrations (sound) from three locations on the knee. The transducers are plugged into an amplifier box that is connected to a standard personal computer installed with Windows 3.1, or later version. A goniometer attachment is also plugged into the amplifier box. The system generates a metronome arrow that moves on the computer monitor screen (3 seconds per flex/extend cycle). The patient watches the arrow to pace the speed and direction of knee flexion and extension, while staying "in sync" with the metronome to maintain a 3 second cycle. Motion and sound vibrations are amplified, recorded in graph form, and stored in a patient database.