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510(k) Data Aggregation

    K Number
    K222782
    Device Name
    Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
    Manufacturer
    Zhejiang Carebao Co., Ltd.
    Date Cleared
    2023-01-13

    (120 days)

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

    Zhejiang Carebao Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wearable 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 Wearable Breast Pump is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device. The software provides control over vacuum pressure and cycle speed. The Wearable Breast Pump series includes ten models: YD-1195, YD-1196,YD-1198,YD-1199:YD-1193S, YD-1195S, YD-1196S, YD-1198S, YD-1199S. All model have a single pumping configuration only and operate in three modes - stimulation, expression, and mixed modes. The Wearable Breast Pump is capable of providing vacuum levels up to 290 mmHg. All modes include 9 vacuum user-selected levels. Models YD-1195, YD-1198, YD-1199, YD-1193S, YD-1196S, YD-1198S and YD-1199S are identical to model YD-1196 except for enclosure color and model name. YD-1196 and YD-1193 have the same suction modes, maximum vacuum, overvoltage protection functions, backflow protection functions, and material composition, but are different in user interface, schematic circuit, appearance and construction. YD-1193, YD-1195, YD-1196,YD-1198,YD-1199 are retailed with one unit per package. YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S are retailed with two units per package. The Wearable Breast Pumps are designed to work under the user's bra and has a rechargeable 3.7V, 1100mAh lithium ion battery so it can be used hands-free without any external power cords. The subject device is charged from an external USB adapter and does not function when charging. The subject device consists of the following key components: the pump unit, connector body, silicone shield, dust cap, top cover, diaphragm, valve, airway tube, bottle, nipple, bottle cap set, bottle stand, and USB cable. The pump unit includes a press-button user interface, pump body, and LED display. The user interface includes user-adjustable controls for turning the device on/off, switching between massage mode and expression mode and mixed mode, and controlling vacuum level within each of the modes. The subject device expresses mills by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection diaphragm physically separates the milk-contacting pathway from the vacuum system.
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    K Number
    K211755
    Device Name
    Electric Breast Pump
    Manufacturer
    Zhejiang Carebao Co., Ltd.
    Date Cleared
    2021-12-01

    (177 days)

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

    Zhejiang Carebao Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electric breast pump is intended to be used by lactating women to express and collect milk from their breast. It is intended for a single user.
    Device Description
    The electric breast pump is an over-the-counter powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment by a single user. The electric breast pump includes three models: YD-1132S, and YD-1168. YD-1130S and YD-1132S has a double pumping from both breasts at the same time) configuration only. YD-1168 has both single pumping (pumping from one breast) and double pumping (pumping from both breasts at the same time) configurations. The electric breast pump is comprised of the pump unit, system parts (including connector body, silicone shield, dust cap, top cover, diaphragm, valve, airway tube, bottle, nipple, bottle cap set, bottle stand), and USB cable. The electric breast pump provides two suction modes: Massage mode and Expression mode, with adjustable vacuum levels and cycle speeds. The device is electrically powered from either an internal rechargeable battery or an external AC power adapter.
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