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510(k) Data Aggregation

    K Number
    K160511
    Device Name
    Naya Breast Pump System
    Manufacturer
    Date Cleared
    2016-06-24

    (121 days)

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

    NAYA HEALTH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Naya Breast Pump System 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.
    Device Description
    The Naya Breast Pump System is a personal use electric breast pump capable of single or double pumping. The device is electrically powered from either an internal rechargeable battery or an external supply. The external supply also charges the battery. The device can also connect to an iPhone (iOS 8.0+) application (Mobile App) that replicates the front panel controls and indicators on the pump. The Naya Breast Pump System may be used in the hospital or home setting. The Pump may be used by different users, but one person at a time. The Distal Breast Assembly (DBA) is intended as a single user component. A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 260 mmHg. The Naya Breast Pump System is powered by a rechargeable battery or from mains. The User Interface with the pump is: - Power Button - Mode Button - Touch Wheel The Mobile App looks identical to the pump user interface in that the same three interface points are present. The device has two modes of operation: - Stimulation Mode: Suction pattern with fast cycles and low vacuum to start milk flowing - Flow Mode: Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
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