BEUDAMED
    Product Code: OVX FDA not classified

    Water Immersion Labor Pool

    Unknown

    The Water Immersion Labor Pool is a device used to provide partial water immersion during labor in hospitals, birth centers, and home settings. It is FDA not classified, meaning it has not been assigned a device class and does not fit neatly into the standard Class 1, 2, or 3 framework. The product code is OVX and it is reviewed under the obstetrics panel. No regulation number has been assigned to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OVX
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    OB
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Partial water immersion during labor in hospitals, birth centers and home.

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.