510(k) clearance
Sway System (Sports Plus)
- 510(k) number
- K262000
- Applicant
- Sway Medical, Inc.
- Decision date
- Oct 18, 2026
- Date received
- Jun 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- POM
- Device type
- Computerized Cognitive Assessment Aid For Concussion
- Device class
- Class II
- Regulation
- 21 CFR 882.1471
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Tulsa, OK, US