BEUDAMED
    Product Code: PJO FDA class 1 21 CFR 880.2400

    Fall Prevention Alarm/Sensor Combination Attached Or Unattached

    General Hospital

    The Fall Prevention Alarm/Sensor Combination (Attached or Unattached) is a patient safety device that can either attach to a person via a clip or belt or be used unattached, where the patient sits upon it, to detect and alarm in fall-risk situations. 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 PJO. This device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PJO
    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

    The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it.

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.