Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K113315
    Device Name
    RUMBLE TUFF
    Date Cleared
    2012-11-20

    (377 days)

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

    ACUTE IDEAS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rumble Tuff Electric Breast Pump is an electrically powered single-user device used to express and collect milk from the breasts of lactating women. The device is not intended for hospital use.
    Device Description
    The Rumble Tuff Electric Breast Pump is a powered Breast Pump. With different models, the Pumping can be performed on one breast or on both breasts at the same time; the Rumble Tuff Electric Breast Pump can be powered by 4 AA batteries, one 7.4V Li batteries or an AC Adapter provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. Rumble Tuff Electric Breast Pump has five models; PA200S, PA201S, PA201D, PA203S, and PA203D. The suffix "S" stands for the model with single collection kit, and "D" stands for the model with dual collection kits. The user interface of PA200S uses 4 LEDs for indicating pumping cycle and uses a roller type adjuster for pumping level adjustment and indicating pumping level. Models PA201S, PA201D, PA203S, and PA203D all use the same user interface, a LCD screen for showing the pumping information; it also uses a roller type adjuster for pumping level adjustment. For all models, the user is able to control the cycle speed and vacuum level.
    Ask a Question

    Ask a specific question about this device

    K Number
    K023711
    Device Name
    DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
    Date Cleared
    2002-11-21

    (17 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACUTE IDEAS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Device measures the human body temperature from oral, axillary, and rectal. -The device is reusable and intended for clinical or home use on people of all ages.
    Device Description
    The Digital Thermometer is an electronic clinical thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans. Classic type and Flexible type have the same indication for use; however, Flexible type has a flexible tip.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1