Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011659880

FEI Number

3011659880

Entity Name

DANYANG NEW HOPE MEDICAL EQUIPMENT CO., LTD

City/State/Country

Danyang Jiangsu, CN

Establishment Address

Building A-10, No. 55 Ziyuan Road, Life Science Industrial Park, Danyang Development Zone, Danyang Jiangsu 212300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Danyang New Hope Medical Equipment Co., Ltd (Owner Number: 10049037)

Owner / Operator Contact Address

Building A-10, No. 55 Ziyuan Road, Life Science Industrial Park, Danyang Development Zone, Danyang, CN-JS 212300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

pliers Operating Table Over Bed Table,Infusion chair, Trolley, Treatment Cart, Mayo Table, Oxygen Cylinder Trolley, Massage Table, Work Table, Massage Table, Standing Frame Wheelchair Electric Hospital Bed Bedside Cabinet Dental Chair Manual Hospital Bed, Examination Couch, Pediatric Bed Commode Chair Activity Chair Medical Lable Crab Bar operating Scissors Walking Stick Knife Humidify bottle Medical Mattress Stainless Steel Dish & Box forceps Stethoscope Garbage Can, Stainless Steel Water Sink, Bath Chair, Ward Screen View Tester Bone Mallets Therapy Bench Walker, Rollator Children and Baby Beds X-ray Protective (clothes/trousers/Aprons/vest/podotheca/glasses/masks) Cupboard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-04-05
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2015-04-05
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2015-04-05
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2015-04-05
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2015-04-05
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2015-04-05
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2019-12-15
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2015-04-05
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2015-04-05
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2020-09-14
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2015-04-05
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2015-04-05
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-04-05
IPS	Cane	Physical Medicine	Class 1	890.3075	2015-04-05
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-04-05
BYO	Bottle, Blow	Anesthesiology	Class 1	868.5220	2015-04-05
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2015-04-05
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-04-05
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2015-04-05
BZS	Stethoscope Head	Anesthesiology	Class 1	868.1930	2015-04-05
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-04-05
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2015-04-05
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-04-05
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2025-04-10
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2015-04-05
FMS	Bed, Pediatric Open Hospital	General Hospital	Class 2	880.5140	2015-04-05
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2015-04-05
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2015-04-05

Official Correspondent

Changhong Zha

US Agent Details

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

Related Public Records

Same Entity

Danyang New Hope Medical Equipment 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011659880. Last updated year: 2026. Please use registration number 3011659880 when referencing this establishment in official correspondence.