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510(k) Data Aggregation

    K Number
    K221598
    Device Name
    Wearable breast pump
    Date Cleared
    2022-12-09

    (190 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mayborn (UK) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
    Device Description
    The Wearable Breast Pump (model: 1203) is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout, and bra adjuster. All components (minus the pump) are reusable and may be manually cleaned. The Wearable Breast Pump includes rotary electric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes. The Wearable Breast Pump is a battery-powered electro-mechanical device that can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed, and pumping history information. All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.
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