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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computerized Cognitive Assessment Aid For Concussion
510(k) Number K262000
Device Name Sway System (Sports Plus)
Applicant
Sway Medical, Inc.
32 S. Lewis Ave.
Tulsa,  OK  74104
Applicant Contact Michael Zagorski
Correspondent
Sway Medical, Inc.
32 S. Lewis Ave.
Tulsa,  OK  74104
Correspondent Contact Michael Zagorski
Regulation Number882.1471
Classification Product Code
POM  
Subsequent Product Code
LXV  
Date Received06/15/2026
Decision Date 10/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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