ImPACT

GUDID 00864127000301

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.

IMPACT APPLICATIONS, INC.

Cause-and-effect assistive training device
Primary Device ID00864127000301
NIH Device Record Keyddef2d87-f576-4996-ac54-074f18a63867
Commercial Distribution StatusIn Commercial Distribution
Brand NameImPACT
Version Model NumberImPACT
Company DUNS805665101
Company NameIMPACT APPLICATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com
Phone877-646-7991
Emailsupport@impacttest.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100864127000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

POMComputerized Cognitive Assessment Aid For Concussion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-29

Devices Manufactured by IMPACT APPLICATIONS, INC.

00864127000356 - ImPACT Quick Test2021-03-15 ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals age
00864127000349 - ImPACT Version 42021-03-08 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion
00864127000332 - Cognitive Impairment Screener2020-12-24
00864127000301 - ImPACT2018-07-06ImPACT 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.
00864127000301 - ImPACT2018-07-06 ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion
00864127000318 - ImPACT Pediatric2018-07-06 ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of
00864127000325 - ImPACT Quick Test2018-07-06 ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals age

Trademark Results [ImPACT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMPACT
IMPACT
98601500 not registered Live/Pending
Marli J. Washington
2024-06-14
IMPACT
IMPACT
98528216 not registered Live/Pending
L'Chef, LLC
2024-04-30
IMPACT
IMPACT
98528203 not registered Live/Pending
L'Chef, LLC
2024-04-30
IMPACT
IMPACT
98502001 not registered Live/Pending
Hornady Manufacturing Company
2024-04-16
IMPACT
IMPACT
98384931 not registered Live/Pending
HCMP, Inc.
2024-01-31
IMPACT
IMPACT
98328305 not registered Live/Pending
The Impact Fund
2023-12-22
IMPACT
IMPACT
98328269 not registered Live/Pending
Indian American Impact
2023-12-22
IMPACT
IMPACT
98299820 not registered Live/Pending
NOBULL, LLC
2023-12-05
IMPACT
IMPACT
98285346 not registered Live/Pending
Lazarex Cancer Foundation
2023-11-26
IMPACT
IMPACT
98277080 not registered Live/Pending
Montage Hotels & Resorts, LLC
2023-11-19
IMPACT
IMPACT
98189133 not registered Live/Pending
Alveo Technologies Inc.
2023-09-20
IMPACT
IMPACT
98090236 not registered Live/Pending
MedTech Global Products LLC
2023-07-18

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