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510(k) Data Aggregation

    K Number
    K200712
    Device Name
    Rumble Tuff Electric Breast Pump
    Manufacturer
    Date Cleared
    2020-04-17

    (30 days)

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

    A Cute Baby, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
    Device Description
    The Rumble Tuff electrically powered breast pumps (models PA219DM and PA210DM) are intended for multi-user use to extract milk from lactating breasts. The PA209DM model is powered by a 9V AC/DC Power Adaptor and/or built-in 7.4V Li-lon battery. The PA210DM model is powered by a 12V AC/DC Power Adaptor and does not have a batter powered option. Pumping can be performed on one breast (single pumping) or on both breasts (double pumping). The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontrolled DC electric motor. The controlling program consists of 3 phases of speed control (Reflex, Swift, and Natural) and various suction settings. The subject devices utilize an LCD screen as a user interface. All patient-contacting and breast milk-contacting materials are identical to the predicate device.
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