Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021376102

FEI Number

3021376102

Entity Name

SHENZHEN ROOT INNOVATION TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenue, Yuncheng Community, Xili Subdistrict, Nanshan District,, Shenzhen Guangdong 518071, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Root Innovation Technology Co., Ltd. (Owner Number: 10083690)

Owner / Operator Contact Address

Room 3301, Aerospace Innovation Building, No. 7013 Liuxian Avenue, Yuncheng Community, Xili Subdistrict,, Nanshan District, Shenzhen, Guangdong, China, 518071, Shenzhen, CN-GD 518071, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241680

PMA Number

N/A

All Registered Proprietary Names

Momcozy Wearable Breast Pump (BP223) Momcozy Wearable Breast Pump (S9 Pro, S12 Pro) Momcozy Wearable Breast Pump (S9 Pro & S12 Pro ); Momcozy Wearable Breast Pump (BP380) Momcozy Wearable Breast Pump (Model BP334) Momcozy Wearable Breast Pump (Model BP380) Momcozy Wearable Breast Pump (Model BP420) Momcozy Wearable Breast Pump kit(Flange, Valve, Milk Collector, Flange Insert, Flange Cover) Momcozy Maternity Belt (Model: YB001,YB002); Momcozy Recovery Belly Belt (Model: RB001) Momcozy Maternity Belt (Model: YB003) MeggO Maternity Ball (Model: MeggO) Momcozy Wearable Breast Pump (Model S10); Momcozy Wearable Breast Pump (Model X1); Baby Nasal Aspirator (Model BN008) Baby Nasal Aspirator (Model BN006) Momcozy Wearable Breast Pump BP137; Momcozy Wearable Breast Pump BP141 Momcozy Nasal Aspirator (Model BN007) Momcozy Wearable Breast Pump(M5); Momcozy Wearable Breast Pump(M5-N) Momcozy Wearable Breast Pump (BP334) BambooFlex 3-in-1 Compression Socks (Model: SO016) MoveWell Sports Compression Socks (Model: SO034) MediStep Compression Socks (Model: SO033) Momcozy Wearable Breast Pump (BP311)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-09-16
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-04-16
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-06-13
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-04-24
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-11-20
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2025-08-05
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2024-11-29
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2026-03-16
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-06-29
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2026-05-27
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2024-03-12
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2026-05-27
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-03-13
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2024-12-23
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2026-01-12
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2024-12-22

Official Correspondent

Athena Pan

US Agent Details

Amy Dong Business: ROOT TECHNOLOGY LTD. Email: regulatory@momcozy.com Phone: (424) 5137016

Related Public Records

Same Entity

Shenzhen Root Innovation Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021376102. Last updated year: 2026. Please use registration number 3021376102 when referencing this establishment in official correspondence.