Express Powered Breast Pump

The Express Powered Breast Pump expresses and collects breast milk using repeated cycles of suction. It is intended for one lactating user in the home and can pump one breast or both…

Registry build 21.09.26

The Express Powered Breast Pump expresses and collects breast milk using repeated cycles of suction. It is intended for one lactating user in the home and can pump one breast or both breasts at the same time.

A motor-driven membrane pump produces the vacuum, which passes through the personal pumping kit to the breast. A diaphragm separates the milk collection space from the pump and tubing. The user selects massage, expression or stimulation mode and adjusts the vacuum level.

Power and Controls

An internal rechargeable lithium-ion battery powers the pump, which can also operate while connected to its AC adapter. Its backlit display shows the pumping mode, suction level, elapsed time and battery level.

40manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (28), Zhejiang (5), Hong Kong (2). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HGX
Manufacturer City Province Registered as Device types
Essentia Industries Ltd. Dong Guan Guangdong Contract manufacturer 31
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Joytech Healthcare Co., Ltd. Hangzhou Zhejiang Contract manufacturer 9
JDI Electronics Factory Dongguan Guangdong Contract manufacturer 7
Guangdong Xinbao Electrical Appliances Holdings Co., Ltd. Foshan Guangdong Contract manufacturer 6
Jiangsu Xinbei Electrical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 6
Shenzhen Jingxintai Houseware Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Huizhou LVB Maternal AND Infant Supplies Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Huizhou Sunwinon Electronics Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Mastars Industries Co., Ltd. Guangdong Guangdong Contract manufacturer 3
Rrdonnelley Dongguan Guangdong Contract manufacturer 3
SFY Intelligent Technology (Suzhou) Co., Ltd. Kunshan Jiangsu Contract manufacturer 3

Showing 12 of 40. All 40 manufacturers in China registered for Pump, Breast, Powered

Record

Regulatory record for Express Powered breast pump
Listed by Hygeia II Medical Group, Inc., United States
FDA product code HGX
Device type Pump, Breast, Powered
Device class Class 2
Regulation 21 CFR 884.5160
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K233136
Record published 2024-07-10

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Express Powered breast pump
Catalogue number Size Status
10-0318 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Spectra Uzinmedicare Co., Ltd. 144
Freemie Dao Health 93
Ameda, Inc. Ameda, Inc. 72
Motif Medical Cimilre Co., Ltd. 47
Momcozy Shenzhen Root Innovation Technology Co., Ltd. 44
Symmetrical Health, LLC Cimilre Co., Ltd. 28
Electric Breast Pump Ningbo Huiyoo Baby Products Co., Ltd. 28
Ameda® Cimilre Co., Ltd. 22
LVB Huizhou LVB Maternal & Infant Supplies Co., Ltd. 17
Vive Vive Health LLC 17
ViveCare Vive Health LLC 16
Stella Baby USA Cimilre Co., Ltd. 15

Showing 12 of 307. All products under Pump, Breast, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K233136 2024-03-13
K212955 2022-03-15
K200406 2020-03-18
K190465 2019-10-18

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer