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The Compact Wearable Pump is intended to express and collect breastmilk from lactating women for the purpose of feeding collected breastmilk to a baby. The Compact Wearable Pump is intended for a single user.

The Compact Wearable Pump is a battery-powered breast pump which consists of the following components: pump body, breast flange, flange insert, diaphragm, manifold disk, collection cup, charging cord, and carrying bag. The subject device is capable of single pumping (using both packaged pumps independently). It is provided non-sterile and can be re-used by a single user. It does not incorporate off-theshelf (OTS) software or wireless technology/mobile app software functionality. The subject device cannot be operated while plugged into AC power. The Compact Wearable Pump is designed to work in a user's bra. The main body includes a press-button user interface, pump body, and LED indicator lights. The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Stimulation mode consists of 8 vacuum levels and fixed cycle speeds when used. Expression mode includes 8 vacuum levels with three different cycle speed configurations that vary duration between suction and let down for further customization by the user. The Compact Wearable Pump is capable of providing vacuum levels from 36-159 mmHg with cycling rates of 1.67-3.04 cycles per second in stimulation mode and vacuum levels from 78-280 mmHg with cycling rates from 0.53-1.99 cycles per second dependent on which expression mode is used. The Compact Wearable Pump is charged with a 5 V DC USB type C adaptor and powered by a 3.8 V, 1300mAh internal rechargeable lithium-ion battery. The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to 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) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The Lansinoh® Smartpump 3.0 Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for a single user.

The Lansinoh Smartpump 3.0 Double Electric Breast Pump is a double electric breast pump intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pumps can be powered by a rechargeable 7.4 V, 1,500 mAh lithium-ion battery or by an AC adapter that is provided with each pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor-controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.

The Lansinoh® Signature Pro™ Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users. The Lansinoh® Smartpump™M Double Electric Breast Pump is intended to express and collect the breasmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.

The Lansinoh Powered Breast Pumps are intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pump can be powered by 6 AA batteries or by an AC adaptor that is provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference. The purpose of this 510(k) is to update the indications for use statement to include use by multiple users. The labeling has been revised to clarify that the collection kits are for single users only and are not to be shared with other users.

The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.

The Powered Breast Pump provides the option of pumping on one breast or on both breasts at the same time. The Powered Breast Pump can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle-mode and suction level. The Powered Breast Pump is capable of providing vacuum levels from 75 to 220 mmHg with 3 different cycle modes. Mothers are able to choose the most comfortable / preferred vacuum level and cyclemode.