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510(k) Data Aggregation

    K Number
    K242125
    Device Name
    Elvie Stride 2
    Date Cleared
    2024-09-27

    (70 days)

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

    Chiaro Technology Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Elvie Stride 2 is a powered breast pump to be used by lactating women to express and collect milk from their breasts. Elvie Stride 2 is intended for a single user.
    Device Description
    The Elvie Stride 2 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 subject devices are capable of expression and stimulation modes with ten associated suction levels for each. The subject device features on/off buttons, level up/down buttons, mode selection buttons, suction level/time LED indicators/battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included cable. The subject device cannot be operated while plugged into AC power. The breast pumps use 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 devices. Elvie Stride 2 includes the Elvie Stride hub, including the existing firmware and mobile application functionality. The device is capable of producing peak suction levels between -35 and -260 mmHg when double pumping. -55 and -300 mmHg when single pumping, and operating at speeds between 52 to 103 cycles per minute for stimulation mode and 28 to 76 cycles per minute for expression mode. There are two available pumping modes with 10 distinct levels of vacuum and cycle speed. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (diaphragm) mechanism. The subject device includes a 28mm breast shield and 5 separate silicone insert sizes (24, 21, 19, 17 and 15 mm). The breast shield may be used with or without the addition of a nipple insert. The cup assembly includes components which are in contact with breastmilk. All food contacting components are composed of food grade material and have been tested to 21 CFR 174-177.
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