Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030522263

FEI Number

3030522263

Entity Name

HEBEI DINGLI MEDICAL APPARATUS AND INSTRUMENT CO., LTD

City/State/Country

HENGSHUI CITY Hebei, CN

Establishment Address

NO. 988, YONGXING E. ROAD, JIZHOU DISTRICT, HENGSHUI CITY Hebei 053200, CN

Establishment Type(s)

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

Owner / Operator

HEBEI DINGLI MEDICAL APPARATUS AND INSTRUMENT CO., LTD (Owner Number: 10089709)

Owner / Operator Contact Address

NO. 988, YONGXING E. ROAD, JIZHOU DISTRICT, HENGSHUI CITY, CN-HE 053200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical Fixing Belt MEDICAL HOSPITAL BED, Examination Bed MEDICAL OXYGEN BAG Emergency Trolley, Transfer Stretcher Trolley Transport Chair ELECTRIC MEDICAL BED Cervical Vertebra Tractor PREVENT BEDSORE AIR MATTRESS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2023-12-30
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2023-12-30
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2023-12-30
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2025-12-21
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2025-03-20
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2023-12-30
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2023-12-30
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2023-12-30

Official Correspondent

Jenny Jenny

US Agent Details

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

Related Public Records

Same Entity

HEBEI DINGLI MEDICAL APPARATUS AND INSTRUMENT 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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013	Winco Mfg., LLC	1	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.

Similar Registrations

Registration Number	Establishment Name	Location
3045031552	HEFEI INTECENT HOUSEHOLD TECHNOLOGY CO., LTD.	Hefei Anhui, CN
3006328839	THERATOGS, INC.	Telluride, CO, US
3013527364	HENGSHUI XUKANG MEDICAL APPLIANCES CO., LTD.	Hengshui City Hebei, CN
3008363392	MOTION THERAPEUTICS	Folsom, CA, US
3017417635	PLANET (ANHUI) INTERNATIONAL CO, LTD	Chuzhou Anhui, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030522263. Last updated year: 2026. Please use registration number 3030522263 when referencing this establishment in official correspondence.