IMPACT APPLICATIONS, INC.

FDA Device Registration & Listing · Itasca, IL, US · Registration 3011279934

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011279934
FEI Number
3011279934
Entity Name
IMPACT APPLICATIONS, INC.
City/State/Country
Itasca, IL, US
Establishment Address
1 Pierce Pl Ste 101c, Itasca, IL 60143, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ImPACT Applications, Inc (Owner Number: 10052764)
Owner / Operator Contact Address
1 Pierce Place, #101C, Itasca, IL 60143, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170551
PMA Number
N/A

All Registered Proprietary Names

ImPACT Version 4 Cognitive Impairment Screener ImPACT Quick Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
POM Computerized Cognitive Assessment Aid For Concussion Neurology Class 2 882.1471 2021-02-27
PTY Computerized Cognitive Assessment Aid, Exempt Neurology Class 2 882.1470 2020-12-14
POM Computerized Cognitive Assessment Aid For Concussion Neurology Class 2 882.1471 2017-07-07

Official Correspondent

Michael Zagorski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ImPACT Applications, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011279934. Last updated year: 2026. Please use registration number 3011279934 when referencing this establishment in official correspondence.
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