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510(k) Data Aggregation
(90 days)
The Momcozy Wearable Breast Pump (Model: BP380,BP380-A,BP380-B,BP380-C,M5,M5-A,M5-B,M5-C) 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.
The Momcozy Wearable Breast Pump is an electrically powered wearable breast pump. There are two product series: Momcozy Wearable Breast Pump M5 series (M5,M5-A,M5-B,M5-C) and Momcozy Wearable Breast Pump BP380 series (BP380,BP380-A,BP380-B,BP380-C).
The differences between M5 series and BP380 series are as follows:
- BP380 series is equipped with Bluetooth functionality, and can be wirelessly operated via Bluetooth connection to a mobile device
- M5 series disables the Bluetooth functionality.
The differences between each model in a series is the color of the main unit.
The device is intended to be used by lactating women to express and collect milk from their breast. The device is not sterile. 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 includes stimulation mode, expression mode, and mixed mode. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get your 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 uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. 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 operated in single/double pumping modes. To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging cable. The user interface consists of buttons and LED display in which the user switches between modes and controls the vacuum pressure. The BP380 series(BP380,BP380-A,BP380-B,BP380-C) can be wirelessly operated via Bluetooth connection to a mobile device. By using app , users can either select one of three preset operating modes. Available modes include Stimulation, Expression and Mixed.
The devices includes a milk collection set that consists of the following: double-sealed flange, flange insert, diaphragm assembly, duckbill valve assembly, milk collector and main unit pump motor. Each component can be purchased separately by the user if needed. The materials of the milk collection set comply with U.S. food-contact safety testing requirements.
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