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510(k) Data Aggregation
K Number
K163183Device Name
Yooeehouse Breast Pump
Manufacturer
Date Cleared
2017-10-02
(322 days)
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Nantong Poly Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Yooeehouse breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
The Yooeehouse pumpset should be used in combination with Yooeehouse breast pump and is intended to be used by lactating women to express and collect milk from their breast. The pumpset can be used both as a single pumpset and as a double pumpset.
Device Description
The subject device is a breast pump that is intended to be a single patient reusable device. The device is used in a home environment and is capable of single and dual pumping. The submission includes four different breast pumps: L08, L10, S08, and S10.
The breast pump uses a USB adapter. The breast pump consists of a pump, a non-sterile pumpset (composed of silicone, polypropylene, acrylonitrile butadiene styrene, and polyphenylene sulfone), and a power adapter. The breast pump has a negative pressure module that utilizes a microcomputer-controlled system to set and adjust the mode (massage or expression), velocity and intensity of stimulation and suction. The vacuum pump component of the device creates the negative pressure used to extract milk from the breast. The vacuum pump is connected to a solenoid valve that provides variable vacuum cycling rates ranging from 24-110 cycles/minutes. In the massage mode, there is single vacuum pressure of 30 mmHg, while the expression mode has vacuum pressures ranging from 60 to 220 mmHg depending on the expression setting selected. A light-emitting diode indicator (Models S08 and S10) or liquid-crystal display (models L08 and L10) indicate the status of operation.
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