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The Freemie® Independence and Freemie® Liberty are powered breast pumps to be used by lactating women to express and collect milk from their breast. The Freemie® Independence and Freemie® Liberty pumps are intended for use by a single user.

The Freemie® Independence and Freemie® Liberty powered breast pumps utilizes the supplied previously cleared device (K130349) Freemie® Breast Pump Collection System to express and collect milk from the breast of a lactating woman. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The system is designed for mobile pumping (home, office, etc.) as the device is light weight, compact in size and can be attached to the user's clothing with a clip. Ten (10) suction levels, eleven (11) cycle speeds and three (3) memory settings (suction and cycle levels) are user adjustable via tactile switches (referred to as buttons). The pumps are powered by a rechargeable lithium-ion polymer battery which can be charged with a USB to micro USB provided cable (laptop, car, etc.) and alternatively with a supplied wall charge adapter with a USB port for charging the battery with mains power. The sole function of the Micro USB port on the pump is for charging the pump. The power to the pump is always supplied by the battery, even when charging. Firmware controls a low voltage DC swash plate vacuum pump and solenoid that is capable of providing vacuum levels from -10 to -280 mmHq with cycle speeds from 18 to 150 cycles per minute. A physical barrier on the collection side prevents backflow of milk into the pump. The Freemie® Independence Pump has a series of LED lights to indicate the pump's current use settings to the user and has a pre-programmed auto shut-off timer that turns the pump off after 40 minutes. The Freemie® Liberty Breast Pump has an LCD screen to indicate the pump's current use settings to the user and has an auto shut-off timer that is user adjustable in five minute increments from 5 to 40 minutes.

The Freemie breast pump collection system is intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk.

The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast funnel, internal valve assembly and enclosing reservoir shaped like a bowl. Additional accessories, associated with the device to replicate the functional and performance characteristics necessary for use with some pump brands, will be sold separately but in conjunction with the sale of the Freemie when those specific brands are identified by the user. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use. The Freemie device is available with two cup variations. The first (identified as "Round" or "Standard") is similar in shape to the predicate Freemie (K111411). The second (referred to as "Shaped" or "Natural" or "Formed") is a shaped cup that is intended to approximate a shape that, for aesthetic purposes, more resembles the natural shape of a breast supported by an ordinary brassiere. Both variants are made from the same materials, function identically and use the same valve and funnel assembly and will be chosen by the user based on individual preference. The interfaces where the cup and cone variants attach to each other are identical. The Freemie will also be available in 3 funnel variants, a 25mm (similar to the predicate Freemie), identified by DAO Health as FG008 (Standard) and FG011 (Form Shape), and larger 28mm (FG009 for the Standard and FG012 for the Form Shape) and 32mm (FG010 for Standard and FG013 for the Form Shape) funnels. All funnel sizes are made from the same material, fit with either of the cup variants and use the same universal valve assembly.

The Freemie milk collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk.

The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast adapter, internal valve assembly and enclosing reservoir shaped like a bowl. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands. Additionally, smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use.