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The Sway System Sports Plus is intended for use as a computerized cognitive assessment and management of concussion in individuals ages 18-24. The Sway System Sports Plus is indicated for use when there is a suspected concussion or head injury.

Sway Sports Plus (referred to as Sway Sports+) is a licensed variant of the Device Sway System and is a software solution (SaMD) that provides a computerized cognitive assessment aid for concussion. This prescription device uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to a suspected concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. The examiner may have the patient complete the Sway Balance test to provide an additional indicator in their assessment of concussion. The Sway System is not intended as a stand-alone diagnostic device. After the patient completes the Sway Sports+ test(s), the examiner can view the summary statistics for each test such as mean reaction time (speed). Sway Sports+ does not create new information through analysis or interpretation, nor does it offer any diagnostic or treatment recommendations. The Sway Sports+ is not intended to be used as a standalone diagnostic device. Sway Sports+ operates in the Apple iOS or Android operating systems, enabling it to be used on the hardware of Apple iPhone. iPad, and iPod Touch. or Android mobile devices. The internal accelerometer is accessed to analyze motion of the device in response to stimuli during testing. The mobile device hardware is not provided by Sway Medical. Environments where Sway Sports+ may be used may include both clinical and non-clinical settings. Clinical settings may include physician offices, hospitals, physical or occupational therapy clinics, skilled nursing facilities, assisted living centers and other healthcare facilities where cognitive tests may be evaluated. In addition, non-clinical environments may include sports team's locations where the application may be used on the sideline to perform a cognitive assessment, e.g., fitness centers, gymnasiums, or stadiums. It is recommended that the tests be taken in a supervised environment for baseline and post-injury testing. Sway Sports+ consists of the Sway Balance (K121590) and the Sway Computerized Cognitive Assessment Aid. The Sway Computerized Cognitive Assessment Aid (PTY) is exempt from 510(k).