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Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk; HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy. The device is intended for individuals with: - spinal cord iniurv at levels C4 to L5 (ASIA C. ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B); - post stroke paresis - paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy) -cerebral palsy and are 12 years or older -spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used inside healthcare facilities while under trained medical supervision in accordance with the user assessment and training certification program.

Medical HAL Lower Limb Type is a battery powered bi-lateral ower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes in 30 size variations (variation same as predicate: 3 different leg lengths, 2 different leg lengths, 2 different waist widths >> total 24. New size variation: 3 different leg configurations, 1 leg lengths, 2 different waist widths >> total 6) and weighs ~9.5 kg (21 lbs). The main difference between the Model ML05 and ML07 is the leglengths. ML05 has S.M, L, XL sizes, while ML07 has 2S sizes. The device uses legally marketed electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level, torque tuner, and balance tuner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (ClC) mode. CAC mode provides assistive torque leg trajectories based on postural cues and sensor shoe measurements. CC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed. Patients must exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. The patient must be supported by a Body Weight Support (BWS) system before and during device use. The BWS must not be detached from the patient before doffing this device. HAL is not intended to provide sit-stand or stand-sit movements. HAL is capable of gait speeds up to approximately 2 km/hour on level ground. HAL is not intended for sports or stairclimbing. In preparation to using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used in conjunction with regular physiotherapy. HAL is intended to be used inside a medical facility under the supervision of trained medical professionals who have successfully completed the HAL training program.

HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy. The device is intended for individuals with: - spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B); - post stroke paresis - paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program

HAL for Medical Use (Lower Limb Type) is a battery powered lower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes. The device comes in 8 size variations (4 different leg lengths and 2 different hip widths) for each of the 3 configuration types (doubleleg, right-leg, and left-leg) and weighs ~14 kg (30 lbs). The device uses legally marketed cutaneous electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals of the hip and knee extensor and flexor muscles when the device is used in Cybernic Voluntary Control (CVC) mode. This mode provides assistive torque at the corresponding ioint (e.g., hip or knee) using surface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the device to detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level, torque turner, and balance turner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (CIC) mode. CAC mode provides assistive torque leg trajectories based on postural cues and sensor shoe measurements. CIC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physician, physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed.

HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy. In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program

HAL for Medical Use (Lower Limb Type) is a battery powered bi-lateral lower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes. The device comes in 8 size variations (4 different leg lengths and 2 different hip widths) and weighs ~14 kg (30 lbs). The device uses legally marketed cutaneous electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals of the hip and knee extensor and flexor muscles when the device is used in Cybernic Voluntary Control (CVC) mode. This mode provides assistive torque at the corresponding joint (e.g., hip or knee) using sufface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the device to detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level. torque turner. and balance turner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (CIC) mode. CAC mode provides assistive torque leq trajectories based on postural cues and sensor shoe measurements. CIC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physician, physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed. Patients must exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. The patient must be supported by a Body Weight Support (BWS) system before donning the device and during device use. The BWS must not be detached from the patient before doffing this device. HAL is not intended to provide sit-stand or stand-sit movements. HAL is capable of gait speeds up to approximately 2 km/hour on level ground. HAL is not intended for sports or stairclimbing. In preparation to using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used in conjunction with regular physiotherapy. HAL is intended to be used inside a medical facility under the supervision of trained medical professionals who have successfully completed the HAL training program.