Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021966508

FEI Number

3021966508

Entity Name

JIANGYIN UNIXCARE MEDICAL DEVICES CO.,LTD

City/State/Country

Jiangyin Jiangsu, CN

Establishment Address

No.326, Huanan Road, Huashi Town,, Jiangyin Jiangsu 214421, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Jiangyin Unixcare Medical Devices Co.,Ltd (Owner Number: 10084205)

Owner / Operator Contact Address

No.326, Huanan Road, Huashi Town,, Jiangyin, CN-JS 214421, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Knee brace Mattress Cover Lift 3 Position Recliner face mask commode, bariatric commode, wheeled commode, Bath Chair, Four-Wheel Bath Chair, No Backrest Bath Chair, Shower Chair, Bath Bench, chair Raised Toilet Seat; Toilet Safety Rail Grab Bar, Reacher, Transfer board, TRAPEZE BAR Rollator, Walker, Knee walker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2022-06-21
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2022-01-25
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2022-01-25
FRJ	Chair, Geriatric	General Hospital	Class 1	880.6140	2022-01-25
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2022-01-25
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2022-01-25
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2022-01-25
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2022-01-25

Official Correspondent

Yihe HOU

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jiangyin Unixcare Medical Devices 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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Similar Registrations

Registration Number	Establishment Name	Location
1022826	FILLAUER, LLC	CHATTANOOGA, TN, US
3007942528	WELLPOWER SPORTING GOODS CO., LTD.	Dong Guan Guangdong, CN
2183520	Tenacious Holdings Inc	Saint Paul, MN, US
3010239526	Simple Manufacturing DG Ltd	Dongguan City Guangdong, CN
3030683078	HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021966508. Last updated year: 2026. Please use registration number 3021966508 when referencing this establishment in official correspondence.