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The Back on Trac (BOTGEN1) and Cervi-Trac Systems are in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder). Back on Trac The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)". The device may be used to manage and reduce pain associated with the following conditions: - facet syndrome, - herniated disc, - protruding disc, - extruded disc, - sciatica, - spondylosis (degenerative disc disease & facet syndrome), - joint pain. Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back. Cervi-Trac The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.

The Ergo-Flex Technologies Systems that are the subject of this premarket notification are prescription use only and are intended for use by licensed, qualified healthcare professionals, such as physicians, chiropractors, physical therapists, etc. Ergo-Flex Back on Trac System: The (BOTGEN1) is comprised of a reclinable therapeutic cushioned chair with back support portion and a second lower back, upper and lower leg support section that is movable in an axial direction with respect to the back support section and is also arcuately movable about a pivot axis that is perpendicular to the axial direction. The chair includes remotely controlled linear actuators to control the relative movement of the different sections of the device. Ergo-Flex Cervi-Trac: The Cervi-Trac (CT) is an accessory to the Back on Trac (BOTGEN1) that focuses specifically on the cervical region. The patient is not restrained by the Back on Trac arm bolsters, therefore lumbar traction is not activated by the Cervi-Trac during this therapy.