Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010334650

FEI Number

3010334650

Entity Name

Jiangsu Xinbei Electrical Appliances CO., LTD.

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

NO. 115 Xinjin Road,, Xinwu District, Wuxi Jiangsu 214000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Xinbei Electrical Appliances Co., Ltd (Owner Number: 10048891)

Owner / Operator Contact Address

NO. 115 Xinjin Road,, Xinwu District, Wuxi, CN-JS 214000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lactation Massager XB-9228, XB-9229 Massager TCG-001 Lactation Massager TCG-003 BB BREAST MASSAGER 423667 TT Electric Breast Pump, Model:1183 TT Electric Breast Pump, Model:1162 electric breast pump MDS68000,MDS68010 Electric Breast Pump XB-8132, XB-8782, XB-8159, XB-8786 NCVI Electric Breast Pump AM8132, AM8782, AM8102, AM8122, AM8129, AM8100 Gradient Compression Socks Postpartum Recovery Support Garment Postpartum Recovery Support Garment for C Section Pregnancy Support Band Model: ZPPRS Zomee Zomee Postpartum Recovery System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2020-07-27
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-02-10
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2016-07-10
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2019-01-06
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2024-03-04

Official Correspondent

Haifeng Shao

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Jiangsu Xinbei Electrical Appliances 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010334650. Last updated year: 2026. Please use registration number 3010334650 when referencing this establishment in official correspondence.