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The Electric Breast Pumps are intended to express and collect milk from the breast of a lactating woman.

The Electric Breast Pump BLA8015-02 is designed and manufactured to express and collect milk from a lactating woman's breast. The subject device is electrically powered, software-controlled, digital single-user pumps. The pump is available in 4 different modes, which are massage mode, continuous express mode, frequency conversion mode and normal express mode. The different modes can be distinguished by different keys displayed on the LCD. There are 6 expression levels for massage mode and continuous expression mode, and 9 expression levels for frequency conversion mode and normal express mode. The suction strengths are different for different working modes. The suction strength can be adjusted within 20~240mmHg by the user. When powered, the subject device starts with massage mode at level 1. The mode switch and level adjustment can be achieved by mode keys. A suction cycle consists of an inhale process and an exhaust process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. When the suction strength reaches the setting value, the vacuum pump stops working and the expressed milk opens the valve and then flows into the bottle due to pressure difference. The pump is provided in non-sterile and can be re-used by a single user. The device has embedded software and the level of concern for the software is minor. The device is powered by Li-ion battery. The patient contact component and milk contact component are massage cushion and milk bottle. The contact duration and contact level is limited skin contact. The massage cushion and milk bottle are respectively made of polypropylene and silicone gel. The materials meet the requirements of FDA regulations concerning food contact. The device can be used in both hospital and home environment.