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510(k) Data Aggregation

    K Number
    K230672
    Device Name
    Annabella Breast Pump
    Manufacturer
    Date Cleared
    2023-08-04

    (147 days)

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

    Annabella Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Annabella Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Breast Pump is intended for a single user.
    Device Description
    The Annabella Breast Pump is a single, electric breast pump system intended to express and collect milk from the breasts of lactating women. It is comprised of a vacuum unit including tubing and a massage unit that mimics the baby's sucking motions. The user employs buttons on the vacuum unit to control the vacuum intensity levels, suction rate as well as the massage unit speed and location on the breast. The device is supplied with a reusable, washable and adjustable breast shield, a bottle lids and a charger. The Annabella is a rechargeable Li-ion battery operated device that contains software. The device cannot be operated while connected to the mains AC Power core. The battery compartment is at the bottom of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day. The device is to be used in the home.
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