BEUDAMED
    Product Code: PJP FDA class 1 21 CFR 880.2400

    Fall Prevention Alarm/Sensor Attached Only

    General Hospital

    The Fall Prevention Alarm/Sensor (Attached Only) is a patient safety device that functions exclusively when attached to a person, typically via a clip or belt, to detect and alarm in fall-risk situations in healthcare settings. It is an FDA Class 1 device regulated under 21 CFR 880.2400, subject to general controls, within the General Hospital (HO) medical specialty. The product code is PJP. This device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PJP
    Device Class
    FDA class 1
    Regulation Number
    880.2400
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

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

    Definition

    This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt .

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.