BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Vera

    K Number: K182333 · Decision Apr 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    3
    Review Days
    224

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    Basic Information

    Device Name
    Vera
    K Number
    K182333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Reflexion Health, Inc.
    Date Received
    August 28, 2018
    Decision Date
    April 9, 2019
    Product Code
    LXJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXJ Interactive Rehabilitation Exercise Devices

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    Other Clearances by Reflexion Health, Inc.

    K Number Device Name
    K192474 VERA
    K150462 Vera