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510(k) Data Aggregation

    K Number
    K191577
    Device Name
    Willow Wearable Breast Pump 2.0
    Manufacturer
    Exploramed NC7, Inc.
    Date Cleared
    2019-09-06

    (84 days)

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

    Exploramed NC7, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Willow Wearable Breast Pump 2.0 is 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 Willow Wearable Breast Pump 2.0 (Willow) is a small electric breast pump that is intended for lactating women to express and collect breast milk. Willow may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, she would need to use two Willow devices at the same time, one on each breast. Willow is for use by a single user only. Willow is a battery-powered electro-mechanical device that contains software. The device includes the following main components: Pump, milk collection component (milk bag or container), and a charger. All milk contacting components of the device are compliant with 21 CFR 174-179. This submission was for clearance of modifications made to the predicate device, including addition of a milk container for milk collection, updates to device firmware, inclusion of Bluetooth for connection to an optional mobile app, and a change in the flange attachment method.
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    K Number
    K161266
    Device Name
    Athena Breast Pump
    Manufacturer
    EXPLORAMED NC7, INC
    Date Cleared
    2016-08-11

    (98 days)

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

    EXPLORAMED NC7, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExploraMed NC7 Athena Breast Pump is 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 ExploraMed NC7 Athena Breast Pump (Athena) is a small electric breast pump that is intended for lactating women to express and collect breast milk. The subject device is intended for multiple uses with a single user. Athena may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, she would need to use two (2) Athena devices at the same time, one on each breast.
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