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510(k) Data Aggregation

    K Number
    K222573
    Device Name
    imani i2Plus Breast Pump
    Manufacturer
    imani Co.
    Date Cleared
    2023-03-03

    (190 days)

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

    imani Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The imani i2Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The imani i2Plus Breast Pump is a single user device.
    Device Description
    The imani i2Plus Breast Pump is an electrically powered wearable single breast pump consisting of the following key components: a funnel, insert, milk collector, valve, protector, charging cable, adaptor, cap, and iBox accessory. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free. The main body includes a press-button user interface, pump body, and LCD display. Pumping can be performed on one breast (single pumping) or two breasts (double pumping) when configured with the iBox accessory. The user interface allows the user to switch from massage to pumping mode and control the vacuum levels within those modes. Massage and pumping modes consist of 5 vacuum levels and fixed cycle speeds when used standalone. Massage mode consists of 5 vacuum levels and 1 cycle speed and pumping mode consists of 9 vacuum levels and 3 cycle speeds for each level. The i2Plus in standalone configuration is capable of providing vacuum levels from 50-150 mmHg at a fixed cycling rate of 65 cycles per minute in massage mode and vacuum levels from 80-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The i2Plus with the iBox accessory is capable of providing vacuum levels from 150-200 mmHg at a fixed cycling rate of 60 cycles per minute in massage mode and vacuum levels from 150-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The imani i2Plus is charged with a 5 V DC USB type C adaptor and powered by a 3.7 V, 1400mAh internal rechargeable lithium-ion battery. The motor unit operates on embedded software updates by endusers 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 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. The i2Plus operates on a rechargeable battery when standalone and does not function when charging. When configured with iBox, the pump is only operable when connected with the AC adapter. The rechargeable battery can be charged using the external USB adapter if the motor unit is not in operation. All milk contacting components are compliant with 21 CFR 174-179.
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    K Number
    K202037
    Device Name
    imani i2
    Manufacturer
    imani Co.
    Date Cleared
    2021-03-01

    (221 days)

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

    imani Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The imani i2 breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The imani i2 breast pump is a single user device.
    Device Description
    The imani i2 is a powered breast pump that is intended to express and collect mills from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). The imani i2 breast pump is a wearable breast pump comprised of a main body (pump), charqing cable, collection bottle, valve, diaphragm for backflow protection, and a breast funnel. It is designed to work in the user's nursing bra and is battery operated so it can be used hands-free without external power cords. The only user-contacting material is polypropylene (breast funnel). The device is provided non-sterile. The imani i2 breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and breast pumping mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 VDC, 1400 mAh). The imani i2 provides the following user features: Two displays for level of vacuum and battery. Five buttons for power on/off, mode selection (Massage Mode, Pumping Mode), decrease vacuum, and increase vacuum Pumping Mode: This mode is used to express and collect milk from the breast. This mode includes five vacuum and cycle speed levels. Massage Mode: This mode is used to massage the breast before pumping. This mode includes five vacuum levels and a consistent single cycle speed across all vacuum levels.
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    K Number
    K202045
    Device Name
    imani i1
    Manufacturer
    imani Co.
    Date Cleared
    2021-02-26

    (218 days)

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

    imani Co.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The imani il is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This device is intended for multiple users.
    Device Description
    The imani i1 breast pump is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The pump component of this device can be used by multiple users using separate collection accessories. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). The imani i1 breast pump is comprised of a main pump body, diaphragm and cap for backflow protection, valve, milk bottle connector, a breastmilk storage packset (30pcs), and air hose hub. The only user-contacting material is polypropylene (breast shield). The device is provided non-sterile. The imani i1 breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and breast pumping mode, are pre-programmed with variable levels and cycle speed (pump speed). The subject device is AC-powered (AC adaptor: 100 - 240 V, 50/60 Hz, 550 mA [Output: 12VDC, 2A]). The imani i1 breast pump provides the following user features: Three displays for level of cycle, time, and vacuum, Eight buttons for power on/off, mode selection, decrease vacuum and cycle, increase vacuum and cycle, and light control, Breast Pumping Mode: This mode is used to express and collect milk from breast. This mode includes 12 vacuum levels and 6 cycle speed levels. Massage Mode: This mode is used to massage the breast before pumping. This mode includes 6 vacuum levels and 2 cycle speed levels.
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