Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011118556

FEI Number

3011118556

Entity Name

HUBEI XINYUNQI HOUSEHOLD PRODUCTS CO., LTD.

City/State/Country

Tongshan Hubei, CN

Establishment Address

Nanlin Ind. Park, Nanlinqiao Town,, Tongshan Hubei 437600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WUHAN WEI & WEN INTERNATIONAL TRADING CO., LTD. (Owner Number: 10047615)

Owner / Operator Contact Address

Nanlin Ind. Park, Nanlinqiao Town,, Tongshan, CN-HB 430023, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CALA PRODUCTS CALA PRODUCTS CALA PRODUCTS CALA PRODUCTS CALA PRODUCTS CALA PRODUCTS CALA PRODUCTS CALA PRODUCTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPS	Cane	Physical Medicine	Class 1	890.3075	2017-11-19
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-04-19
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2024-02-22
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2018-12-07
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2016-04-19
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2022-02-21
JES	Floss, Dental	Dental	Class 1	872.6390	2024-03-06
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2017-11-19

Official Correspondent

TONY XU

US Agent Details

Sharon Luo Business: Ariel Premium Supply Email: sharonl@arielpremium.com Phone: (314) 7870737

Related Public Records

Same Entity

WUHAN WEI & WEN INTERNATIONAL TRADING 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3017496567	ALIGNED AS DESIGNED, LLC	Pasadena, CA, US
8043549	HMS-VILGO	BERGERAC, CEDEX Dordogne, FR
3034731542	GUANCHI TECHNOLOGY (HEBEI) CO., LTD.	Hengshui Hebei, CN
3016678414	FOSHAN FEIYANG MEDICAL EQUIPMENT CO., LTD.	Foshan Guangdong, CN
1422443	DMS HOLDINGS, INC.,	Waukegan, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011118556. Last updated year: 2026. Please use registration number 3011118556 when referencing this establishment in official correspondence.