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The electric breast pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for a single user, not for hospital use.

The electric breast pump is designed and manufactured by the Shantou Xinghe Electrical Apparatuses Co., Ltd. It is intended to express and collect milk from breast from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for a single user, not for hospital use. Model XN-2201M1, XN-2201M3, XN-2206M2, XN-2207M1, XN-2209M1, XN-2210M2 are included in this submission. The electric breast pump imitates a baby's sucking action to express milk with help of Single-Chip Microcomputer. It has multiple stimulation levels for breast massage, and multiple milk quantity of a baby's suction. The keyboard of the device control panel is soft. The screen is an LCD, and allows for process viewing.

The electric breast pump is to express and collect milk from breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for single user.

The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed and manufactured by the Shantou Xinghe Electrical Apparatus Co., Ltd. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mother and baby occur. Two models of this device, Horigen, XN- 2203H2 and Droplet, XN-2203H4, are included in this Premarket Notification submission. The primary differences between the two models, Horigen XN- 2203H2 and Droplet, XN-2203H4 are the shape of the breast shield and the settings of the stimulating velocity, stimulating intensity, sucking velocity and sucking intensity. The specific settings are listing under the summary of non-clinical tests. The product uses a Single-Chip Microcomputer to imitate a baby's suckling action. The device is ergometrically designed to create comfortable milk stimulation, massage, and suction from the breast. Three (3) stimulation levels and five (5) speeds are available to imitate the rhythm and action of a baby's suckling. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm. The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed to mechanically interface with a mother's breast via a breast shield and withdraw, then collect, the breast milk. The device is driven by a microcomputer which electrically controls piston components. The pistons perform a reciprocating movement in the device cylinder and pump seat. A breast cup is fixed between the piston and the piston head on which negative and positive pressure is created by the piston action. A mobile magnet detects the mechanical movement and creates an electrical signal to the microcontroller.