Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017538926

FEI Number

3017538926

Entity Name

CHANGZHOU JIYUAN SEWING & MANUFACTURE CO.,LTD.

City/State/Country

CHANGZHOU CITY Jiangsu, CN

Establishment Address

YINCUN ZOUQU TOWN ZHONGLOU DISTRICT, CHANGZHOU CITY Jiangsu 213147, CN

Establishment Type(s)

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

Owner / Operator

CHANGZHOU JIYUAN SEWING & MANUFACTURE CO.,LTD. (Owner Number: 10090163)

Owner / Operator Contact Address

YINCUN ZOUQU TOWN ZHONGLOU DISTRICT, CHANGZHOU CITY, CN-JS 213147, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PILL ORGANIZER CANE; QUAD CANE FEET WRIST BRACE RAISED TOILET SEAT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2024-02-22
IPS	Cane	Physical Medicine	Class 1	890.3075	2024-02-22
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-02-22
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2024-02-22

Official Correspondent

Xiangping Qian

US Agent Details

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

Related Public Records

Same Entity

CHANGZHOU JIYUAN SEWING & MANUFACTURE 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017538926. Last updated year: 2026. Please use registration number 3017538926 when referencing this establishment in official correspondence.