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510(k) Data Aggregation

    K Number
    K173699
    Device Name
    The Pump by Babyation
    Manufacturer
    Date Cleared
    2018-04-04

    (121 days)

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

    Babyation, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pump by Babyation is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts. The Pump by Babyation can be used by multiple users.
    Device Description
    The Pump by Babyation is a multiple-user powered breast pump system that allows lactating women to discreetly express and collect milk. It is powered by a rechargeable lithium ion battery. Users have the option of single or double pumping. The device has two phases of pumping, stimulation and expression. Stimulation phase is characterized by faster cycle times and lower suction levels and is used to initiate milk letdown. Expression phase is characterized by slower cycle times and higher suction levels and is used after milk letdown has occurred. The device consists of a main enclosure which houses all of the electrical components that control the system and the pneumatic components that generate suction at vacuum levels up to 250mmHg. The main enclosure also provides an insulated storage area for one ice pack, milk collection bottles, breast shields, and the necessary tubing for the system. The device also includes a mobile app that connects to the device via Bluetooth and allows the user to control the pump.
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