Data / Medical devices / United States / Impact Applications, Inc.
Impact Applications, Inc.: FDA-registered device maker in Itasca, IL, United States, 3 510(k) clearances
Impact Applications, Inc. is registered with the FDA (registration 3011279934) in Itasca, IL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 25, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011279934
- Address
- 1 Pierce Pl Ste 101c, Itasca, IL, United States, 60143
- Owner or operator
- ImPACT Applications, Inc (10052764)
- Roles
- Manufacturer
- First device listed
- October 5, 2016
- Registered through
- 2026
- Brand names listed
- Cognitive Impairment Screener, ImPACT, ImPACT Pediatric, ImPACT Quick Test, ImPACT Version 4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computerized Cognitive Assessment Aid For Concussion | POM | 2 | Manufacturer | accessdata.fda.gov |
| Computerized Cognitive Assessment Aid, Exempt | PTY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 25, 2020 | K202485 | ImPACT Version 4 | POM | Substantially Equivalent | Impact Applications, Inc. | accessdata.fda.gov |
| June 21, 2017 | K170551 | ImPACT Quick Test | POM | Substantially Equivalent | Impact Applications, Inc. | accessdata.fda.gov |
| August 22, 2016 | DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | POM | Unknown | Impact Applications, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Computerized Cognitive Assessment Aid For Concussion
- All makers of Computerized Cognitive Assessment Aid, Exempt
Updated December 25, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.