Symmetrical Health, LLC

This is powered breast pump intended to express and collect milk from the breasts of lactating women. The final product is packed in a box with necessary connecting parts including backflow…

Registry build 21.09.26

This is powered breast pump intended to express and collect milk from the breasts of lactating women. The final product is packed in a box with necessary connecting parts including backflow protector, tubing, valves, bottle, power adapter, flanges, locking rings, locking cap and user manual, so the user can use the device right after receiving them.

40manufacturers in China registered for this device type
28catalogue numbers in this listing
3510(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 Symmetrical Health, LLC
Listed by Cimilre Co., Ltd., South Korea
FDA product code HGX
Device type Pump, Breast, Powered
Device class Class 2
Regulation 21 CFR 884.5160
Establishment Manufacturer
Record published 2021-04-07
Record revised 2021-11-15 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Storage environment humidity 20 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 50 °C
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Symmetrical Health, LLC
Catalogue number Size Status
cimilre S5+ In distribution
CIMILRE Backflow Protector- set of 2 In distribution
CM0A21 In distribution
CIMILRE Power Adapter (1) In distribution
Cimilre S6 plus In distribution
CIMILRE Bottle set-set of 2(No cap and nipple) In distribution
CIMILRE Collection kit 28mm -set of 2 In distribution
CIMILRE Tubing -set of 2 In distribution
cimilre UL Adapter In distribution
CIMILRE 28mm shield set of 2 In distribution
CM0A22 In distribution
cimilre UL A,USB-C Cable SET In distribution
CM0A14-19 In distribution
cimilre P1 In distribution
CIMILRE Duckbill Valve – set 0f 2 In distribution
Wide silicone Nipple Set In distribution
CIMILRE 24mm shield set of 2 In distribution
cimilre collection kit 32mm In distribution
Cimilre S6 In distribution
CIMILRE Skinny Neck Adapter – set of 2 In distribution
cimilre collection kit 21mm In distribution
S7_DUAL_PRO_S7-100-00-00 In distribution
CIMILRE 32mm shield set of 2 In distribution
CIMILRE 21mm shield set 0f 2 In distribution
cimilre E1 In distribution
CM0A20 In distribution
CIMILRE Collection kit 24mm- set of 2 In distribution
CIMILRE Car Charger (1) 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
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
Unimom Unimom Co. 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
K260643 2026-08-21
K221708 2022-12-23
K162870 2017-03-07

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