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The Wearable Breast Pump (Model W12) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W12) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; it is intended for a single user. The Wearable Breast Pump (Model W12) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and massage modes and control the vacuum levels within those modes. The Wearable Breast Pump (Model W12) also includes a 'Hot Compress' mode not associated with any vacuum pressure or cycle speed. When enabled, the flange is heated, the symbol indicating heating will light up, and the maximum temperature is <= 42 degrees C.

All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model W12) is capable of providing vacuum levels from 40-150 mmHg with cycling rates from 86-127 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 34-109 cycles per minute in expression mode, vacuum levels from 40-245 mmHg with cycling rates from 34-130 cycles per minute in auto mode, and vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in massage mode. The Wearable Breast Pump (Model W12) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device is not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

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