Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015698523

FEI Number

3015698523

Entity Name

CHANGZHOU ELITE INTERNATIONAL CO.,LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

ZOUQU TOWN ZHONGLOU DISTRICT, Changzhou Jiangsu 213147, CN

Establishment Type(s)

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

Owner / Operator

CHANGZHOU ELITE INTERNATIONAL CO.,LTD (Owner Number: 10060998)

Owner / Operator Contact Address

ZOUQU TOWN ZHONGLOU DISTRICT, Changzhou, CN-JS 213147, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RECHARGEABLE TOOTHBRUSH & REPLACEMENT HEAD Walker Glides RAISED TOILET SEAT UNDER PAD; CHAIR PAD; SHEET SET WRIST BRACE PILL ORGANIZER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2019-07-26
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2019-08-19
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2020-02-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2019-07-26
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2020-08-27
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2019-07-26

Official Correspondent

LILI JIANG

US Agent Details

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

Related Public Records

Same Entity

CHANGZHOU ELITE INTERNATIONAL 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 3015698523. Last updated year: 2026. Please use registration number 3015698523 when referencing this establishment in official correspondence.