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The Hygeia Express Powered Breast Pump is a powered breast pump intended to express and collect milk from the breasts of a lactating woman. It is intended for a single user only.

The Hygeia Express Powered Breast Pump is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The device consists of a pump, Personal Accessory Set (PAS) pumping kit, and an AC adapter. The pump is also configurable with a wearable PAS kit which allows milk to flow into a cup pressed against the breast during use. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The Hygeia Express Powered Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four buttons allowing the user to power the device on/off, select between three pumping modes (massage, expression, and stimulation), and control vacuum strength within each mode (9 levels of vacuum strength in each mode). The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The breast pump uses cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the device. The device is capable of producing peak suction levels between -50 and -250 ± 25 mmHg in at speeds between 20 and 150 ± 5 cycles per minute. There are 3 available pumping modes with 9 distinct levels of vacuum and cycle speed. When connected to the pump, the PAS pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination. 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 FIT Pro Breast Pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The FIT Pro Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium-ion battery. The device is provided non-sterile. The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping). The FIT Pro Breast Pump utilizes a DC-powered motor driving a diaphragmtype vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies. The FIT Pro Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four softtouch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, and control vacuum strength within each mode (6 levels of vacuum strength in stimulation mode and 12 levels in expression mode). The FIT Pro Breast Pump is intended for a single user in the home environment. When properly connected, the Hygeia PAS pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination. The base model of the FIT Pro Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard.

The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

The Evolve Breast Pump, the subject device, is an electrically powered breast pump from an external AC-DC power supply or internal, rechargeable batteries; the device is provided non-sterile. The subject device is a cordless version of the predicate device. The Evolve Breast Pump is intended to be used by lactating women to express and collect mills from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The breast pump is designed as a multi-user breast pump and is available as a cordless model powered by an internal, rechargeable Lithium lon battery or an external AC-DC power supply. The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women. The Evolve Breast Pump has a backlit, LCD display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression – and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes. The Evolve Breast Pump is intended for repeated use by multiple users in the home environment. The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

The Evolve Breast Pump, is an electrically powered breast pump from an external AC-DC power supply; the device is provided non-sterile. The Evolve Breast Pump is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The Evolve breast pump is designed as a multi-user breast pump and available in a corded model (external AC-DC power supply). The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women. The Evolve Breast Pump has a backlit, LCD display for user display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression - and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes. The Evolve Breast Pump is intended for repeated use by multiple users in home environment. The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.