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The Wearable Breast Pump, Model S18 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump, Model S18 is an electrically powered breast pump to be used in home environment by a single user. The device is provided non-sterile and can be re-used by a single user. The device is electrically powered by an internal rechargeable Li-ion battery. It can be charged using 5V DC adaptor and the device is designed to be not used during charging. The device consists of the pump motor, milk collection parts, adjustment buckle and charging cable. The device functionality is controlled using an embedded firmware. The subject device has three modes of operation - Expression mode, Stimulation mode and Massage mode, and each mode of operation allows for switching between nine suction levels. The device has three buttons, a power button to turn the device on/off or switch between the modes, a '+ plus' button to increase the suction level and a '- minus' to decrease the suction level within a mode. The device includes an LED status display for the device operating mode and battery status indicator on the pump body. The operating mode LED changes to specific color based on the mode of operation. The device is designed to automatically shut down after 30 minutes of continuous operation. The device operates on a suction(vacuum) cycle that consists of an inhale (letting in air to release vacuum) and an exhaust (removal of air to create vacuum) process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. Once the suction strength reaches the set value, the vacuum pump stops and the valve for the milk opens and expressed milk flows into the bottle due to a pressure difference. All milk contacting components of the device are compliant with 21 CFR 177.