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510(k) Data Aggregation

    K Number
    K033696
    Device Name
    PERSONAL INJECTOR
    Manufacturer
    UNION MEDICO APS
    Date Cleared
    2005-02-16

    (449 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNION MEDICO APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Personal Injector is intended for use by patients to self-administer or by care-givers for injection of FDA approved drugs or biologics. Personal Injector is intended to introduce the needle below the skin surface. Personal Injector is designed to accommodate two different and replaceable syringeholders. Personal Injector is intended for the use with FDA approved fixed or non-fixed needle syringes supplied with specific injection reqimens. Personal Injector is intended to be used in any setting including the home.
    Device Description
    Personal Injector is designed for the user - by a user, and here for a lot of emphasis has been put on functionality and injection comfort, appearance, surface, materials, weight, balance, and sound. Personal Injector is an injection system allowing the user to have maximum control and comfort while injecting. Personal Injector differs from commonly known Auto-injector. Until today, marketed Autoinjectors are only for subcutaneous injections, and introduce both the needle and the drug in one motion. The injections are associated with discomfort, such as pain, blue marks, drug accumulation and swelling at the injection site. Personal Injector has a spring-loaded mechanism that only serves to introduce the needle to a pre-determined depth, either subcutaneous or intramuscular. Hereafter the patient can check for air bobbles and vein penetration, and perform a safe traditional manual injection of the drug, by slowly and steady pushing the plunger down. Personal Injector minimises pain and support the patient perform the manual drug introduction, avoiding almost all discomfort. Personal Injector two unique Syringe-Holders is designed to accommodate FDA approved syringes with fixed and non-fixed needles. Personal Injector is suitable for many injection regimes, including multiple sclerosis patients treatment with interferon beta, cancer treatment, children receiving growth hormone treatment, men injecting local vasodilators to treat erectile dysfunction, and injections of heparin, adrenaline, insulin, apomorphine, and many others medications.
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