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510(k) Data Aggregation
K Number
K201903Device Name
Electric breast pump (Models: RH-228 and RH-338)
Manufacturer
Cixi Ruihong Electric Appliance Co., Ltd.
Date Cleared
2021-04-09
(275 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Cixi Ruihong Electric Appliance 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 a single-patient reusable device, intended to be used by lactating women to express and collect milk from their breasts. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The Electric breast pump has two models: RH-228 and RH-338. Model RH-228 is capable of single pumping and has two modes - stimulate mode and expression mode. The RH-228 user interface consists of a panel keypad and LED display in which the user switches between modes and controls the vacuum pressure. Model RH-338 is capable of single pumping and has three modes - stimulate mode, massage mode and expression mode. The RH-338 user interface consists of a panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure. The RH-228 is externally powered by 5Vdc USB. The RH-338 is internally powered by 3.7Vdc lithium battery or externally powered by 5Vdc USB. The external adapter also charges the battery. Both models of the Electric breast pump are provided with a breast shield, cylinder cap, cylinder, valve, vacuum tubing, feeding bottle, and a nipple kit. Model RH-338 also includes a massage cushion and a dust cap. The user-contacting materials are limited to polypropylene (breast shield) and silicone (massage cushion).
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