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510(k) Data Aggregation

    K Number
    K210936
    Device Name
    Elvie Stride
    Manufacturer
    Chiaro Technology Limited
    Date Cleared
    2021-08-25

    (149 days)

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

    Chiaro Technology Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elvie Stride is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Stride is intended for a single user.
    Device Description
    Elvie Stride is an electric breast pump that is intended for lactating women to express and collect breast milk. It is intended for a single user. It may be operated as a single or double pumping system. Elvie Stride has adopted the in-bra aesthetic. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without any external power cords. The pump is located off the body and the milk collection bottle is located on the breast. It expresses milk by applying negative pressure to the nipple so that expressed milk may collect in the milk collection bottle. It can be controlled through the physical interface on the pump or through a mobile companion app. Elvie Stride consists of 15 components: Hub, Breast Shield, Cup Front, Diaphragm Seal, Valve, Stopper, Tubing, Tube Splitter, Hub Connector, Cover, Cup Seal, Cap, Cap Seal, Clip and USB Charging Cable. All components are reusable and may be manually cleaned or placed on the top shelf of a dish washer.
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    K Number
    K181863
    Device Name
    Elvie Pump
    Manufacturer
    Chiaro Technology Limited
    Date Cleared
    2018-10-10

    (90 days)

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

    Chiaro Technology Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elvie Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Pump is intended for a single user.
    Device Description
    The Elvie Pump is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout and bra adjustor. All components (minus the pump) are reusable and may be manually cleaned. The kit components may be purchased separately and are available in different sizes and configurations. The Elvie Pump includes piezoelectric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes. The Elvie Pump is a battery-powered electro-mechanical device that contains software. It can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed and pumping history information. All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.
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