K241737 is an FDA 510(k) clearance for the Sway System Sports Plus. This device is classified as a Computerized Cognitive Assessment Aid For Concussion (Class II - Special Controls, product code POM).
Submitted by Sway Medical, Inc. (Tulsa, US). The FDA issued a Cleared decision on February 15, 2025, 243 days after receiving the submission on June 17, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1471. For Use As An Assessment Aid In The Management Of Concussion..
| 510(k) Number | K241737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2024 |
| Decision Date | February 15, 2025 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | POM - Computerized Cognitive Assessment Aid For Concussion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1471 |
| Definition | For Use As An Assessment Aid In The Management Of Concussion. |