FDA.reportPublic FDA data

ImPACT Quick Test

Primary DI
00864127000356
Brand
ImPACT Quick Test
Company
IMPACT APPLICATIONS, INC.
Model
2
Device description
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
Published
2021-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
POMComputerized Cognitive Assessment Aid For Concussion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POMComputerized Cognitive Assessment Aid For ConcussionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170551000ImPACT Quick TestImpact Applications, Inc.2017-06-21POM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864127000356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864127000356008641270003568641270003560864127000356

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive assessment softwareA software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-646-7991support@impacttest.com

Regulatory Flags#

DUNS number
805665101
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864127000349ImPACT Version 442021-02-27
00864127000325ImPACT Quick Test12017-07-31
00864127000301ImPACTImPACT2016-11-29
00864127000332Cognitive Impairment Screener12020-12-16
00864127000318ImPACT PediatricImPACT Pediatric2016-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00868168000306SwayHEALTHY ROSTER LLCPOM2026-04-13
00860334002138ANAM Test System: Military, Military Expanded, Core, Core Expanded, and SportsVISTA PARTNERS, LLCPOM2025-11-24
00860334002121ANAM Test System: Military, Military Expanded, Core, Core Expanded, and SportsVISTA PARTNERS, LLCPOM2023-08-04
00864127000349ImPACT Version 4IMPACT APPLICATIONS, INC.POM2021-02-27
00864127000325ImPACT Quick TestIMPACT APPLICATIONS, INC.POM2017-07-31
00864127000301ImPACTIMPACT APPLICATIONS, INC.POM2016-11-29
00864127000318ImPACT PediatricIMPACT APPLICATIONS, INC.POM2016-11-29