Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010359088

FEI Number

3010359088

Entity Name

LINGXIAN DONGSHENG TEXTILE CO., LTD.

City/State/Country

Dezhou Shandong, CN

Establishment Address

Dali Village, Yidukou Town, Lingxian County,, Dezhou Shandong 253506, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Lingxian Dongsheng Textile Co., LTD. (Owner Number: 10043922)

Owner / Operator Contact Address

Dali Village, Yidukou Town, Lingxian County,, Dezhou, CN-SD 253506, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SUPPORT, CANNULATION, W/O STRAP Medline Isolation Gown Manual Bed MEDLINE WHEELCHAIR DRAINAGE BAG HOLDER protector heel MDSSLIDE5848 Non-AC-powered patient lift Freedom Splints Medline examination gown MDSHBBPET, MDSHBBSML, MDSHBBMED, MDSHBBLRG, MDSHBBXLG, MDSHBB2XL Medline Gait Belt Medigrip tubular bandages Med-Glide patient positioning sheet, Medline Bariatric Transfer Sheet, Knitted sheet Medline Economy Vest Mattress cover for medical purposes, Felt mattress pad Medical disposable bedding, TPF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOD	Board, Arm (With Cover), Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2024-06-14
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2014-10-22
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2025-04-27
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2016-12-20
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2022-09-23
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2019-07-05
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2025-11-23
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2023-11-05
FME	Gown, Examination	General Hospital	Class 1	880.6265	2013-04-05
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2025-11-23
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2016-09-23
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2018-11-06
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2014-02-18
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2014-07-11
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2019-03-21
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2021-02-09

Official Correspondent

Matt Clausen

US Agent Details

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

Related Public Records

Same Entity

Lingxian Dongsheng Textile 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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Similar Registrations

Registration Number	Establishment Name	Location
1226711	TARRY MEDICAL PRODUCTS, INC.	DANBURY, CT, US
3008950799	JOEANNE DOMINICANA DIVISION OF JOEANNE COMPANY INTERNATIONAL	Santiago, DO
3008494300	Shaoxing Songqiao Textile Co, ltd	Shaoxing Zhejiang, CN
1218386	ALIMED, LLC	DEDHAM, MA, US
3011859755	Brady (Xiamen) Co. Ltd.	Xiamen Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010359088. Last updated year: 2026. Please use registration number 3010359088 when referencing this establishment in official correspondence.