Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011669224

FEI Number

3011669224

Entity Name

JIAXING XINYI MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Jiashan City Zhejiang, CN

Establishment Address

No.15,Jinyi Road,(1)and No.100 Zhijiang Road,, (2) Economic Development Zone Jiashan City Zhejiang, CHINA, Jiashan City Zhejiang 314100, CN

Establishment Type(s)

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

Owner / Operator

Jiaxing Xinyi Medical Instrument Co., Ltd. (Owner Number: 10049114)

Owner / Operator Contact Address

No.15,Jinyi Road,(1)and No.100 Zhijiang Road,, (2) Economic Development Zone Jiashan City Zhejiang, CHINA, Jiashan City, CN-ZJ 314100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

manual bed steel rollator aluminum rollator steel walker with castors aluminum walker with castors disposable face mask disposable face mask Wheelchair polio auxiliary cane underarm crutch single hand cane tips and pads cane crutch and walker aluminum shower chair with backrest aluminum commode steel commode with castors round shower chair disposable face mask Protective clothing Isolation Gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2015-04-15
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2015-04-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-25
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-25
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2018-01-18
IPS	Cane	Physical Medicine	Class 1	890.3075	2015-04-15
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2015-04-15
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-04-15
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	2020-03-29
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-29

Official Correspondent

Charles Shen

US Agent Details

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

Related Public Records

Same Entity

Jiaxing Xinyi Medical 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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011669224. Last updated year: 2026. Please use registration number 3011669224 when referencing this establishment in official correspondence.