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510(k) Data Aggregation

    K Number
    K232477
    Device Name
    Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
    Date Cleared
    2024-05-09

    (267 days)

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

    **Jiangxi AOV Maternity **& Baby Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, and AOV6852) is a powered breast pump to be used by lactating women to express and collect milk from their breast Pump is intended for a single user.
    Device Description
    The subject devices, Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, AOV6852), are powered breast pumps to be used by lactating women to express and collect milk from their breast. The proposed devices are battery powered, software-controlled, and intended for a single user. The devices are intended for home use. The subject devices have the following modes: Massage mode, Expression mode, Bionic mode, Frequency Conversion mode A, Frequency Conversion mode B, Continuous suck mode and Mixed mode; each mode has multiple levels. Massage mode is for stimulating breast milk secretion. Expression mode is for pumping breast milk. Bionic mode cycles between massaging for 2 cycles and expressing for 2 cycles. Frequency Conversion mode A cycles between massaging for 3 cycles and expressing for 1 cycle. Frequency Conversion mode B cycles between massaging for 3 cycles and expressing for 2 cycles. Continuous suck mode applies a lower suction followed by a hold and then a second increase in suction before release as a cycle. Finally, Mixed mode cycles between massaging for 3 cycles and expressing for 1 cycle at levels 1-6, then cycles between massaging for 3 cycles and expressing for 2 cycles at levels 7-9. The subject devices can be used in a single or double pumping configuration and have anti-backflow protection. The subject devices have a USB connecting cable and matching power adapter to supply power to the device. The subject devices are provided non-sterile and are not to be sterilized by the user prior to use. Each device includes a breast shield assembly, collection bottles, tubing set, feeding accessories, power adapter (for charging), and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body, which contacts the user's breast.
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