FDA.reportPublic FDA data

ImPACT

Primary DI
00864127000301
Brand
ImPACT
Company
IMPACT APPLICATIONS, INC.
Model
ImPACT
Device description
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.
Published
2016-11-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
DEN150037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150037000ImPACT Computerized Neurocognitive Concussion Management AidImpact Applications, Inc.2016-08-22POM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864127000301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864127000301008641270003018641270003010864127000301

GMDN Terms#

Term, Definition table
TermDefinition
Cause-and-effect assistive training deviceA device designed to be used to assist a person with a disability with developing an understanding of cause and effect (i.e., what is the reason for something to happen and what will be the outcome should it happen).

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
00864127000356ImPACT Quick Test22021-03-05
00864127000349ImPACT Version 442021-02-27
00864127000325ImPACT Quick Test12017-07-31
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
00864127000356ImPACT Quick TestIMPACT APPLICATIONS, INC.POM2021-03-05
00864127000349ImPACT Version 4IMPACT APPLICATIONS, INC.POM2021-02-27
00864127000325ImPACT Quick TestIMPACT APPLICATIONS, INC.POM2017-07-31
00864127000318ImPACT PediatricIMPACT APPLICATIONS, INC.POM2016-11-29