impacttest.comImPACT Version 4
Impact Applications, Inc.
IMPACT APPLICATIONS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011279934 | 3011279934 | IMPACT APPLICATIONS, INC. | 1 | N | 2026-01-01 | 1 Pierce Pl Ste 101c Itasca IL US 60143 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00864127000301 | ImPACT - ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59. | 877-646-7991 | support@impacttest.com |
| 00864127000318 | ImPACT Pediatric - ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11. | 877.646.7991 | support@impacttest.com |
| 00864127000325 | ImPACT Quick Test - ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70 | 877-646-7991 | support@impacttest.com |
| 00864127000349 | ImPACT Version 4 - ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80. | 877-646-7991 | support@impacttest.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 199037 | 1447882738 | K202485 | ImPACT Version 4 | POM | 2020-12-25 |
| 199037 | 1836271857 | K170551 | ImPACT Quick Test | POM | 2017-06-21 |
| 199037 | 1528692038 | DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | POM | 2016-08-22 |
| 199037 | 1835633720 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| POM | 3 | 2020-12-25 |
PMN#
ImPACT Version 4
ImPACT Applications, Inc.
ImPACT
ImPACT Applications, Inc.
ImPACT Quick Test
ImPACT Applications, Inc.
ImPACT
IMPACT APPLICATIONS, INC
GUDID#
ImPACT Quick Test - ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
2021-03-05
ImPACT Version 4 - ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
2021-02-27
ImPACT Quick Test - ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
2017-07-31
ImPACT - ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-59.
2016-11-29
Cognitive Impairment Screener - 1
2020-12-16
ImPACT Pediatric - ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 5-11.
2016-11-29