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The Motion InBra (YM-8801) wearable breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Motion InBra (YM-8801) powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.

The Motion InBra (YM-8801) wearable breast pump 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 Motion InBra (YM-8801) is a breast pump powered by lithium-ion battery, utilizing an embedded control program to manage all device functions. The user interface allows the user to switch from stimulation and expression modes and control the vacuum levels within those modes.

All available modes consist of 9 vacuum levels. The Motion InBra (YM-8801) is capable of providing vacuum levels from 80-160 mmHg with cycling rates from 100-120 cycles per minute in stimulation mode and vacuum levels from 80-280 mmHg with cycling rates from 35-75 cycles per minute in expression mode. The device 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 adaptor if the motor unit is not in operation.

The Motion InBra Wearable Breast Pump includes 2-Phase Expression Technology: Stimulation and Expression Phases. The Stimulation Phase initiates with a rapid suction pattern designed to trigger the milk ejection reflex and promote milk flow. In contrast, the Expression Phase begins with a slower and deeper suction rhythm, optimized for effective milk extraction once let-down has occurred. 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.

The operating life of the Motion InBra Wearable Breast Pump is 150 hours. The expected operating life of the washable parts (milk container, breast shield, insert and membrane) is 3 months.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 175 and 21 CFR 177.

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