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510(k) Data Aggregation

    K Number
    K212564
    Device Name
    Electric Breast Pump
    Date Cleared
    2022-05-06

    (266 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Guangdong Horigen Mother **& Baby Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breasts, to alleviate engorgement of the breasts, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This electric breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
    Device Description
    The Electric Breast Pump is a multi-user electric breast pump designed for lactating women to express and collect milk from the breast. It is intended for use in the hospital and home environments and can also be used by a single user. The device is an electrically powered pump consisting of the following key components: a flange, breast shield body, silicone diaphragm, tubing/tubing connector, pump motor, AC/DC adapter, and milk collector. The Electric Breast Pump contains two models, SMG and GEA. Both models can be operated in single and double pumping modes while connected to AC power and have an onboard rechargeable lithium-ion battery. The SMG model has an LCD display, and the user can select between stimulation or expression mode. Stimulation mode has 5 vacuum levels and expression mode has 16 vacuum levels. For every vacuum level, the user can independently select among 9 cycle speed levels (for stimulation) and 16 cycle speeds (for expression up to vacuum level 11; higher vacuum levels have less available cycle speeds). The SMG model is wirelessly operable via Bluetooth connection to a smart device. The GEA model also has an LCD display, and the user can select stimulation or expression mode. Stimulation mode and expression mode have 10 levels. Stimulation speed is set to 70 cycles per minute, whereas expression mode allows for cycling speed between 3 levels. Both devices operate via an electric negative pressure module that runs discontinuously to generate periodic negative pressure suction and are controlled by a magnetic valve for negative pressure adjustment. Each vacuum pump operates with a DC motor and corresponding DC power supply. Both devices have a 40 min stimulation and expression duration. To prevent milk from flowing into the vacuum, a backflow protection mechanism physically separates the milk-contacting pathway from the vacuum system.
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    K Number
    K201152
    Device Name
    Electric Breast Pump
    Date Cleared
    2021-05-04

    (370 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Guangdong Horigen Mother **& Baby Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment.
    Device Description
    The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This Electric Breast Pump is intended for a single user in a home or hospital environment. The Electric Breast Pump has two models: XN/MS-2224A and XN/MS-2224B. Both models are capable of single and double pumping and have two modes: stimulation and expression mode. Both models can be operated using AC power, a built-in rechargeable li-ion polymer battery, or AA batteries.
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    K Number
    K201974
    Device Name
    Single-use medical face mask
    Date Cleared
    2021-03-07

    (235 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Guangdong Horigen Mother **& Baby Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Single-use medical face mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
    Device Description
    The proposed device is single-use medical face mask. It is non-sterile and for single use. The single-use medical face mask is manufactured with three-layers, the inner and outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip. It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.
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    K Number
    K193449
    Device Name
    Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
    Date Cleared
    2020-09-11

    (273 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Guangdong Horigen Mother **& Baby Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended for a single user.
    Device Description
    The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) are electric breast pumps that are intended for lactating women to express and collect breast milk. The Electric Breast Pump and Electric Double Breast Pump are intended for a single user and are to be used in the home environment. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053_01) are Li-ion-battery powered breast pumps that include following main components: the expressed milk collection kit, the pump unit, and tubing. The expressed milk collection kit includes a funnel cover, silicone cushion, funnel adapter, membrane, valve body, valve membrane cap, and milk bottle. The pump unit contains a chip that controls the work of the vacuum pump and solenoid valve to draw air inside of the funnel adapter to form negative pressure. The tubing has two connectors on the two ends. The user attaches the connector to the air vent of the membrane cap and the connector to the pump unit separately to ensure a tight fit.
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    K Number
    K182413
    Device Name
    Electric Breast Pump
    Date Cleared
    2019-03-07

    (184 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Guangdong Horigen Mother **& Baby Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump is intended for a single user.
    Device Description
    The Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting for a single user. It comprises of a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer. This electric breast pump has a negative pressure module that utilizes a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk expression speed intensities. The keyboard of the control panel is soft. The screen is an LCD or LED screen, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 30 to 247.5 mmHg with cycle rates up to 100 cycles per minute.
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    K Number
    K162747
    Device Name
    Proture Double Electric Breast Pump
    Date Cleared
    2016-12-08

    (69 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Guangdong Horigen Mother **& Baby Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Proture Double Electric Breast Pump to be used by lactating women in a home setting to express and collect milk from their breasts. This device is intended for a single user.
    Device Description
    The Proture Double Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting and is for a single user. It comprises a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer. This electric breast pump imitates baby's sucking rhythm with help of a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk suction speed intensities to imitate rhythm of a baby's suction. The keyboard of the control panel is soft. The screen is an LCD, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 15 to 247 mmHg with cycle rates up to 107 cycles per minute. The Proture Double Electric Breast Pump provides the following user features: - Closed system with anti-backflow - LCD screen touch button operation - 2-phase expression: Stimulation and Expression phases - Stimulation Phase: Suction pattern with fast cycles (53-107 cycles/min) and low vacuum (15-120mmHg) to start milk flowing, 5 levels - Expression Phase: Suction pattern with slower cycles (19~47T/min) and higher vacuum (82-247mmHg) to express milk, 9 levels - Double-pumping ability: single or double pumping - Dual power source: it can be operated by A/C adapter or batteries All parts of the device that directly contact with breast and milk are to be sanitized by boiling in water for 5 minutes, followed by drying with a clean towel. After use, all parts that directly contact the breast and milk are to be cleaned in warm, soapy water.
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