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510(k) Data Aggregation

    K Number
    K231688
    Device Name
    ImPACT Version 4
    Manufacturer
    ImPACT Applications, Inc.
    Date Cleared
    2023-09-16

    (99 days)

    Product Code
    POM
    Regulation Number
    882.1471
    Why did this record match?
    Applicant Name (Manufacturer) :

    ImPACT Applications, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImPACT is intended for use as a computer-based neurocogntive 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.
    Device Description
    ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery that allows healthcare professionals to conduct a series of tests on individuals to gather data related to the neurocognitive functioning of the test subject. This test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, spatial processing speed, and records symptoms of a test subject. ImPACT Version 4 is similar to the paper-and-pencil neuropsychological tests that have long been used by psychologists to evaluate cognition, and memory related to a wide variety of disabilities. The device is not intended to provide a direct diagnosis or a return-to-activity recommendation, it does not directly manage or provide any treatment recommendations, and any interpretation of the results should be made only by qualified healthcare professional. The neurocognitive assessment represents only one aspect of assisting healthcare professionals in evaluating and managing individuals with cognitive function impairment related to TBI (concussion).
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    K Number
    K202485
    Device Name
    ImPACT Version 4
    Manufacturer
    ImPACT Applications, Inc.
    Date Cleared
    2020-12-25

    (116 days)

    Product Code
    POM
    Regulation Number
    882.1471
    Why did this record match?
    Applicant Name (Manufacturer) :

    ImPACT Applications, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 measures of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
    Device Description
    ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery that allows healthcare professionals to conduct a series of tests on individuals to gather data related to the neurocognitive functioning of the test subject. This test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, spatial processing speed, and records symptoms of a test subject. ImPACT Version 4 is similar to the paper-and-pencil neuropsychological tests that have long been used by psychologists to evaluate cognition, and memory related to a wide variety of disabilities. The device is not intended to provide a direct diagnosis or a return-to-activity recommendation, it does not directly manage or provide any treatment recommendations, and any interpretation of the results should be made only by qualified healthcare professional. The neurocognitive assessment represents only one aspect of assisting healthcare professionals in evaluating and managing individuals with cognitive function impairment related to TBI (concussion).
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    K Number
    K181223
    Device Name
    ImPACT
    Manufacturer
    ImPACT Applications, Inc.
    Date Cleared
    2018-10-20

    (165 days)

    Product Code
    POM
    Regulation Number
    882.1471
    Why did this record match?
    Applicant Name (Manufacturer) :

    ImPACT Applications, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery. lmPACT is a software-based tool that allows healthcare professionals to conduct a series of neurocognitive tests on individuals to gather basic data related to the neurocognitive functioning of the test subject. This computerized cognitive test battery evaluates and provides a healthcare professional with measures of various neurocognitive functions, including the reaction time, memory, attention, spatial processing speed and symptoms of an individual. lmPACT provides healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices and is intended to be used as part of a multidisciplinary approach to making return to activity decisions.
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    K Number
    K170551
    Device Name
    ImPACT Quick Test
    Manufacturer
    ImPACT Applications, Inc.
    Date Cleared
    2017-06-21

    (117 days)

    Product Code
    POM
    Regulation Number
    882.1471
    Why did this record match?
    Applicant Name (Manufacturer) :

    ImPACT Applications, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImPACT Quick Test is intended for use as a computerized cognitive test aid in the assessment and management of concussion in individuals ages 12-70.
    Device Description
    ImPACT Quick Test (ImPACT) QT is a brief computerized neurocognitive test designed to assist trained healthcare professionals in determining a patient's status after a suspected concussion. ImPACT QT provides basic data related to neurocognitive functioning, including working memory, processing speed, reaction time, and symptom recording. ImPACT QT is designed to be a brief 5-7 minute iPad-based test to aid sideline personnel and first responders in determining if an athlete/individual is in need of further evaluation or is able to immediately return to activity. ImPACT QT is not a substitute for a full neuropsychological evaluation or a more comprehensive computerized neurocognitive test (such as ImPACT).
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    K Number
    K170209
    Device Name
    ImPACT
    Manufacturer
    IMPACT APPLICATIONS, INC
    Date Cleared
    2017-02-23

    (30 days)

    Product Code
    POM
    Regulation Number
    882.1471
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPACT APPLICATIONS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery. ImPACT is a software-based tool that allows healthcare professionals to conduct a series of neurocognitive tests on individuals to gather basic data related to the neurocognitive functioning of the test subject. This computerized cognitive test battery evaluates and provides a healthcare professional with measures of various neurocognitive functions, including the reaction time, memory, attention, spatial processing speed and symptoms of an individual. ImPACT provides healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices and is intended to be used as part of a multidisciplinary approach to making return to activity decisions.
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    K Number
    DEN150037
    Device Name
    ImPACT Computerized Neurocognitive Concussion Management Aid
    Manufacturer
    IMPACT APPLICATIONS, INC.
    Date Cleared
    2016-08-22

    (377 days)

    Product Code
    POM
    Regulation Number
    882.1471
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPACT APPLICATIONS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 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.
    Device Description
    ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) and ImPACT Pediatric are computer-based neurocognitive test batteries for use as an assessment aid in the management of concussion. ImPACT and ImPACT Pediatric are software-based tools that allows healthcare professionals to conduct a series of neurocognitive tests that provide data related to the neurocognitive functioning of the test taker. This computerized neurocognitive test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker. ImPACT and ImPACT Pediatric provide healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices. The devices are intended to be used as part of a multidisciplinary approach to concussion assessment and patient management.
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