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    Product Classification

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    vinoth kumar

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    Product Classification

    Uploaded by

    vinoth kumar
    2 views2 pages

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    © © All Rights Reserved

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    Copyright:

    © All Rights Reserved
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    2 views2 pages

    Product Classification

    Uploaded by

    vinoth kumar

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    FDA Home3 Medical Devices4 Databases5

    Product Classification
    New Search Back to Search Results

    Device Interactive Rehabilitation Exercise Device, Prescription Use


    Regulation Description Measuring exercise equipment.
    Definition
    A prescription device intended to provide interactive rehabilitation
    environment by providing exercises for users to perform.
    Physical State The device employs sensors, a camera, and a screen to track
    user movement and provide visual feedback.
    Technical Method The device employs sensors, a camera, and a screen to track
    user movement and provide visual feedback.
    Target Area The device targets the limbs, trunk, and joints.
    Regulation Medical Specialty Physical Medicine
    Review Panel Physical Medicine
    Product Code QKC
    Premarket Review Office of Neurological and Physical Medicine Devices6 (OHT5)
    Neuromodulation and Rehabilitation Devices (DHT5B)
    Submission Type 510(K) Exempt
    Regulation Number 890.53607
    Device Class 2
    Total Product Life Cycle (TPLC) TPLC Product Code Report8
    GMP Exempt? No
    Summary Malfunction
    Ineligible
    Reporting
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class
    II (special controls) devices9 subject to certain limitations, that are exempt from premarket
    notification requirements under the Food and Drug Administration Modernization Act of 1997
    (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions
    will relieve manufacturers from the need to submit premarket notification submissions for these
    devices and will enable FDA to redirect the resources that would be spent on reviewing such
    submissions to more significant public health issues. FDA is taking this action in order to meet
    requirements of FDAMA and the Cures Act.
    Implanted Device? No
    Life-Sustain/Support Device? No
    Third Party Review Not Third Party Eligible

    Links on this page:


    1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
    2. http://www.addthis.com/bookmark.php
    3. https://www.fda.gov/
    4. https://www.fda.gov/Medical-Devices
    5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
    6. https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization#OHT5
    7. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5360
    8. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=5587
    9. /scripts/cdrh/cfdocs/cfpcd/315.cfm

    Page Last Updated: 04/15/2024


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    Links on this page:


    1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
    2. http://www.addthis.com/bookmark.php
    3. https://www.fda.gov/
    4. https://www.fda.gov/Medical-Devices
    5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
    6. https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization#OHT5
    7. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5360
    8. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=5587
    9. /scripts/cdrh/cfdocs/cfpcd/315.cfm

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