Regulatory
Sway is the first ever FDA Cleared 510K Class II MedicalDevice that combines balance and cognition into one mobile tool for concussion management.
Concussion Management
Sway is the first ever FDA Cleared 510K Class II Medical Device that combines balance and cognition into one mobile tool for concussion management. Sway’s clearance under CFR21.882.1471 has rewritten the standard for concussion management tools to align with NCAA and consensus standards that include balance and cognitive assessment in athletes with suspected concussion.
510K Clearances
Sway is the first ever FDA Cleared 510K Class II Medical Device that combines balance and cognition into one mobile tool for concussion management. Sway’s clearance under CFR21.882.1471 is our second clearance and has rewritten the standard for concussion management tools to align with NCAA and consensus standards that include balance and cognitive assessment in athletes with potential concussion.
MDSAP and ISO13485
Sway has a robust quality system in place to meet regulatory standards for MDSAP and ISO13485. Sway undergoes multiple audits annually to maintain certification with our notified body Intertek. Sway is the only company in the concussion management space to maintain MDSAP and ISO13485 certification.
Sway is Global
Sway is cleared in 34 countries across the world including the United States, Canada, the European Union, the United Kingdom, Australia, and South Africa.
Concussion Management as a Medical Device
Sway Sports+ is classified as a Class II medical device with 510(k) clearance from the FDA under 21CFR882.1471 as a computerized cognitive assessment aid for the management of concussion. This classification requires FDA review of extensive special controls that cover device reliability, validity, and clinical performance. Sway Sports+ is not intended to be the sole determinant of a clinical diagnosis, but rather just one measure in the management of concusion.
Sway Sports+ is intended for use as a computerized cognitive assessment test to aid in the assessment and management of concussion in individuals ages 18-24.
Sway Sports+ is indicated for use when there is a suspected concussion or head injury.
Balance Testing as a Medical Device
Sway Balance is classified as a FDA cleared Class II medical device. Sway Balance is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses, and physicians.
Sway Balance is a medical device and should only be administered with a full understanding of the testing procedure in a controlled environment on a flat, hard surface to ensure test repeatability. Sway Balance does not identify the presence or absence of clinical diagnoses, and is not intended as a stand-alone or adjunctive diagnostic device.
Sway Balance is contraindicated for balance assessment of hospitalized patients and individuals with compromised balance.
Cognitive Testing as a Medical Device
Sway Cognitive is classified as a FDA Class II 510K Exempt computerized cognitive assessment aid intended to provide an interpretation of the current level of cognitive function of an individual based on a battery of cognitive tasks. Sway Cognitive does not identify the presence or absence of clinical diagnoses and is not intended as a stand-alone or adjunctive diagnostic device. Sway Cognitive may only be used under the supervision of a practitioner licensed by law to direct its use.
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