Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253283
    Date Cleared
    2025-10-29

    (30 days)

    Product Code
    Regulation Number
    884.5160
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

    Device Description

    The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP434-, BP420-, BP431-, BP432-, BP400-) is a wearable powered breast pump intended to be used by lactating women to express and collect milk from their breast. The device is a non-sterile reusable device to be used by single user. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device is electrically powered through a rechargeable Lithium battery (3.7V) that can be charged using the USB cable provided with the device.

    The subject device includes three operating modes, namely - stimulation mode, expression mode, and mixed mode, with 15 levels of operation within each mode and a maximum suction of -315mmHg. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get the milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device features a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed during milk expression.

    The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use.

    The device can be connected wirelessly to a mobile device through Bluetooth and be operated through a dedicated mobile application (Mobile flow). By using the application, users can either select one of three preset operating modes or define a personalized mode. The personalized mode supports personalized sessions, each of which can select its own mode, suction level, and duration. Users can also enable a milk overflow reminder function in the app. Pumping output can also be recorded and tracked by users in the app.

    The device is available in one or two pumps in a pack to allow for single/double pumping. The subject device includes an LED display that displays information regarding working mode, running time, suction level, battery status, full milk indicator and Bluetooth indicator. The user interface includes on/off/pause switch, mode selection switch, decrease pumping level, increase pumping level and Toggle button to select breast pump direction to left or right. The subject device includes a diaphragm to prevent milk backflow into the vacuum system as well as software based overflow protection.

    The device includes a milk collection set that consists of the following: double-sealed flange (Polyphenylsulfone (PPSU) + Silicone), flange insert, diaphragm assembly, duckbill valve assembly, milk collector (Tritan) and main unit pump motor. Each component can be purchased separately by the user if needed.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1