ImPACT
FDA 510(k) clearance K170209 · decided 2017-02-23
Clearance details
- K-number
- K170209
- Device name
- ImPACT
- Applicant
- Impact Applications, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-24
- Decision date
- 2017-02-23
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- POM
- Device class
- 2
- Regulation number
- 882.1471
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sway System Sports Plus (K241737) | Sway Medical, Inc. | 2025-02-15 |
| ImPACT Version 4 (K231688) | Impact Applications, Inc. | 2023-09-16 |
| ANAM Test System (K201376) | Vista Lifesciences, Inc. | 2021-03-25 |
| 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 Computerized Neurocognitive Concussion Management Aid (DEN150037) | Impact Applications, Inc. | 2016-08-22 |
Recalls involving this device
No recalls on record reference this clearance.