Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009302777

FEI Number

3009302777

Entity Name

CHANGZHOU 3 BEARS IMPORT/EXPORT CO. LTD

City/State/Country

Tianning District Jiangsu, CN

Establishment Address

1 Xiqi Road, Qinglong, Tianning District Jiangsu 213017, CN

Establishment Type(s)

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

Owner / Operator

Changzhou 3 Bears Import/Export Co. Ltd (Owner Number: 10086654)

Owner / Operator Contact Address

1 Xiqi Road, Qinglong, Tianning District, CN-JS 213017, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091482

PMA Number

N/A

All Registered Proprietary Names

HVR2 Bariatric Walker HVR1 Walker Staxi Transport Chair Accessories Staxi Transport Chair Cushions HVX2 Wheelchair HVX1 Wheelchair HVX3 Wheelchair HVX3 Max Wheelchair HVX1 Wheelchair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2022-11-30
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2022-11-30
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2022-11-30
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2022-11-30
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2022-11-30

Official Correspondent

Lee Hancox

US Agent Details

Melanie Tomlinson Email: melaniet@staxi.com Phone: (470) 2042875

Related Public Records

Same Entity

Changzhou 3 Bears 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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20

Similar Registrations

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3014336266	SUZHOU HY MEDICAL TRADING CO., LTD	Taicang Jiangsu, CN
3027498086	CHARMING WORLD INC.	Taipei City, TW
3039346864	FIRST NATION GROUP, LLC	Niceville, FL, US
3029740428	ORA MEDICAL INC	Montreal Quebec, CA
3014214233	CORE MOBILITY SOLUTIONS	Los Gatos, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009302777. Last updated year: 2026. Please use registration number 3009302777 when referencing this establishment in official correspondence.