BEUDAMED
    Product Code: HGZ FDA class 2 21 CFR 884.5390

    Heater, Perineal, Direct Contact

    Obstetrics/Gynecology

    The Direct-Contact Perineal Heater is a device that applies therapeutic warmth directly to the perineal area through physical contact, used postpartum to promote healing, reduce discomfort, or relieve perineal pain following childbirth or episiotomy. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty. The product code is HGZ, regulated under 21 CFR 884.5390. No special risk flags apply.

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    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HGZ
    Device Class
    FDA class 2
    Regulation Number
    884.5390
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K921885 E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.