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

    IEVA REHABILITATIVE POSITIONAL DEVICE

    K Number: K133990 · Decision Oct 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    1
    Review Days
    286

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    Basic Information

    Device Name
    IEVA REHABILITATIVE POSITIONAL DEVICE
    K Number
    K133990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remendium Labs, LLC
    Date Received
    December 27, 2013
    Decision Date
    October 9, 2014
    Product Code
    HIR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIR Perineometer

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