BEUDAMED
    Product Code: MZT FDA class 2 21 CFR 868.5115

    Device, Heimlich Maneuver Assist

    Anesthesiology

    The Heimlich Maneuver Assist Device is an anesthesiology device designed to assist individuals in performing the Heimlich maneuver more effectively to relieve choking caused by foreign body airway obstruction. It is intended to help bystanders or patients apply adequate abdominal thrust force to dislodge the obstruction. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 868.5115 (Anesthesiology specialty). This device carries the life-sustaining support flag given its role in airway emergencies.

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

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    Basic Information

    Product Code
    MZT
    Device Class
    FDA class 2
    Regulation Number
    868.5115
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    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
    DEN000004 QUICKAIR CHOKE RELIEVER, MODEL 59-001A

    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.