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510(k) Data Aggregation

    K Number
    K963435
    Device Name
    ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE
    Date Cleared
    1996-11-06

    (68 days)

    Product Code
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZIMMER PATIENT CARE DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide. suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances. Finally, these restraints are labeled with the prescription legend, and thus. should only be used on the order of a physician.
    Device Description
    Vest Restraints
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