Sway System Sports Plus
FDA 510(k) clearance K241737 · decided 2025-02-15
Clearance details
- K-number
- K241737
- Device name
- Sway System Sports Plus
- Applicant
- Sway Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-17
- Decision date
- 2025-02-15
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- POM
- Device class
- 2
- Regulation number
- 882.1471
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Tulsa, OK, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| ImPACT Version 4 (K231688) | Impact Applications, Inc. | 2023-09-16 |
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| ImPACT Version 4 (K202485) | Impact Applications, Inc. | 2020-12-25 |
| ImPACT (K181223) | Impact Applications, Inc. | 2018-10-20 |
| ImPACT Quick Test (K170551) | Impact Applications, Inc. | 2017-06-21 |
| ImPACT (K170209) | Impact Applications, Inc. | 2017-02-23 |
| ImPACT Computerized Neurocognitive Concussion Management Aid (DEN150037) | Impact Applications, Inc. | 2016-08-22 |
Recalls involving this device
No recalls on record reference this clearance.