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510(k) Data Aggregation

    K Number
    K231785
    Device Name
    Perifit Pump
    Manufacturer
    X6 Innovations
    Date Cleared
    2024-01-26

    (220 days)

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

    X6 Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Perifit Pump is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
    Device Description
    The Perifit Pump is an electrically powered wearable single breast pump consisting of the following key components: a housing ("hub") containing pump electronics (motor, valve, PCB, rechargeable battery and associated components), and detachable milk-contacting components: a silicone flange (breast shield), a plastic (polypropylene) connector, silicone diaphragm, a silicone duckbill valve, a plastic bottle. Accessories provided with the Perifit Pump include a screw-on container lid, a USB charging cable, and bra adjustment buckle. The Perifit pump is a closed-system breast pump. The hub user interface allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 8 vacuum levels, capable of providing suction from 30 to 285 mmHg, with cycle speeds ranging from 68 to 120 cycles per minute in stimulation mode and 28 to 80 cycles per minute in expression mode. The Perifit Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1500mAh). The breast pump cannot be operated while it is being charged. The Perifit Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment. An optional smartphone app may be used with the Perifit Pump. The app may be used to control the operation of the breast pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Perifit Pump. The Perifit Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.
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    K Number
    K231780
    Device Name
    Perifit Care+
    Manufacturer
    X6 Innovations
    Date Cleared
    2023-12-20

    (187 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    X6 Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Perifit Care+ is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. Perifit Care+ is indicated for an adult female.
    Device Description
    The Perifit Care+ device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.
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    K Number
    K221476
    Device Name
    Perifit
    Manufacturer
    X6 Innovations
    Date Cleared
    2023-02-10

    (266 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    X6 Innovations

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. Perifit is indicated for an adult female.
    Device Description
    The Perifit device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.
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