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510(k) Data Aggregation

    K Number
    K971561
    Device Name
    PROVEST-PROTECTIVE RESTRAINT
    Manufacturer
    JEMM MEDICAL PRODUCTS
    Date Cleared
    1997-07-14

    (76 days)

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

    JEMM MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.
    Device Description
    ProVest - Protective Restraint
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