BEUDAMED
    Product Code: PWA FDA class 1 21 CFR 884.5150

    Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

    Obstetrics/Gynecology

    The Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure is an obstetrics/gynecology accessory device designed to be used in conjunction with powered or non-powered breast pumps, applying positive pressure to the breast to aid in milk expression in nursing women. It is classified as FDA Class I under regulation 21 CFR 884.5150, subject only to general controls and exempt from the premarket notification (510(k)) requirement. The product code is PWA and it falls under the Obstetrics/Gynecology medical specialty. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PWA
    Device Class
    FDA class 1
    Regulation Number
    884.5150
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

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

    Definition

    Designed to be used in conjunction with powered or non-powered breast pumps to apply positive pressure to the breast to aid in milk expression from the breasts of a nursing woman.

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.