Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004905643

FEI Number

3004905643

Entity Name

NINGBO NINGYUAN IMPORT & EXPORT CO., LTD.

City/State/Country

NINGBO, ZHEJIANG, CN

Establishment Address

11F, NEW CONTIENT GINZA, NO 88 QIANHE, SOUTH RD. YINZHOU DISTRICT, NINGBO, ZHEJIANG 315000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NingBo NingYuan Import&Export Co.,Ltd. (Owner Number: 9066584)

Owner / Operator Contact Address

11F, New Contient Ginza No.88 QianHe, South Rd. YinZhou District, NINGBO, ZHEJIANG, CN-NOTA 315000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOSIS, LIMB BRACE FIBER, MEDICAL, ABSORBENT TOOTH BRUSH CRIMPER, WIRE, ENT, NON-STERILE ADAPTOR, RECREATIONAL COMPONENTS, WHEELCHAIR LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED EXERCISER, NON-MEASURING TIPS AND PADS, CANE, CRUTCH AND WALKER Accessories, operating-room, table (kit) CANE SUPPORT, ARM SLING, ARM ADAPTOR, HYGIENE TIMER COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT COVER, MATTRESS (MEDICAL PURPOSES) SCALE ARMREST ACCESSORY, SURGICAL APPAREL TAPE AND BANDAGE, ADHESIVE COVER, SHOE, OPERATING-ROOM CUSHION CHAIR, EXAMINATION AND TREATMENT TOURNIQUET, PNEUMATIC SUPPORT, PATIENT POSITION FORCEPS POST OP SHOE ACCESSORIES, WHEELCHAIR MIRROR, GENERAL & PLASTIC SURGERY SPLINT, HAND, AND COMPONENTS PERCUSSOR FILE PROTECTOR, SKIN PRESSURE BAG, ICE ESTHESIOMETER TRANSFER DEVICE AID, TRANSFER HELMET, CRANIAL, FOR PROTECTIVE USE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2009-05-04
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2014-03-27
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2011-09-08
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2014-03-19
NNN	Crimper, Wire, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2011-09-08
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2004-09-10
KNN	Components, Wheelchair	Physical Medicine	Class 1	890.3920	2009-05-04
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2011-09-08
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2011-09-08
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2014-03-27
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2014-03-27
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2008-12-16
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2009-05-04
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2009-05-04
IMZ	Holder, Crutch And Cane, Wheelchair	Physical Medicine	Class 1	890.3910	2014-03-27
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2015-08-21
IPS	Cane	Physical Medicine	Class 1	890.3075	2013-08-09
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2009-05-04
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2014-03-27
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2009-05-04
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2014-03-27
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2010-07-26
JBS	Timer, General Laboratory	Clinical Chemistry	Class 1	862.2050	2009-05-04
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2009-05-04
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2014-03-27
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2011-09-08
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2014-03-27
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2011-09-08
IKW	Utensil, Homemaking	Physical Medicine	Class 1	890.5050	2014-03-27
IML	Armrest, Wheelchair	Physical Medicine	Class 1	890.3920	2013-09-17
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2011-09-08
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2014-05-01
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2014-03-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2011-09-08
NOD	Board, Arm (With Cover), Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2014-03-27
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2011-09-08
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2020-08-30
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2013-09-17
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2014-03-27
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2009-05-04
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2008-12-16
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2009-05-04
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2011-09-08
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2013-01-28
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2011-09-08
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2016-11-30
KQX	Goniometer, Ac-Powered	Orthopedic	Class 1	888.1500	2015-09-25
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2009-05-04
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-09-08
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2016-07-25
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2012-02-03
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2014-03-27
GWZ	Percussor	Neurology	Class 1	882.1700	2011-09-08
HTP	File	Orthopedic	Class 1	888.4540	2011-09-08
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2009-05-04
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2011-09-08
GXB	Esthesiometer	Neurology	Class 1	882.1500	2011-02-03
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2013-10-31
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2004-09-10
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2011-08-22
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2014-03-27
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2009-05-04

Official Correspondent

Tom Yang

US Agent Details

Diana Rogers Business: ASP Global Email: diana.rogers@aspglobal.com Phone: (404) 6966999

Related Public Records

Same Entity

NingBo NingYuan Import&Export 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

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-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004905643. Last updated year: 2026. Please use registration number 3004905643 when referencing this establishment in official correspondence.