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510(k) Data Aggregation

    K Number
    K210748
    Device Name
    Well-life TM Pen Needles, Well-life TM Safety Pen Needles
    Date Cleared
    2022-05-25

    (439 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    W. L. Med Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for use with pen injector devices for the subcutaneous injection of insulin.
    Device Description
    The Well-life™ Safety Pen Needles and Well-life™ Pen Needles are single use, sterile, disposable medical devices intended to be used with compatible insulin pen injectors. The pen needles are intended for use by adults and pediatrics in a home, clinical, or hospital environment. The devices are sterilized by Ethylene Oxide (EO) to a sterility assurance level of 10 °. The Well-life™ Pen Needles consist of a Needle, Hub, Needle Cap, and Sterile Cap. The Well-life™ Safety Pen Needles consist of a Needle, Hub, Needle Cap, Sterile Cap, Guide, Safety Cap, and Spring. To use the devices, the Needle Hub is screwed onto a compatible pen injector. The Well-life™ Safety Pen Needle (i.e., S type) is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin, the Needle Cap will retract. After the injection is completed and needle is removed from the skin, the safety cap will automatically extend to cover the needle. Once the pen needle is locked out, it can no longer be used.
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