Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019842343

FEI Number

3019842343

Entity Name

NINGBO BAICHEN MEDICAL DEVICES CO., LTD

City/State/Country

Ningbo City Zhejiang, CN

Establishment Address

Room 2101, No.666 Taikang Middle Road, Yinzhou District, Ningbo City Zhejiang 315000, CN

Establishment Type(s)

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

Owner / Operator

Ningbo Baichen Medical Devices Co., Ltd (Owner Number: 10088801)

Owner / Operator Contact Address

Room 2101, No.666 Taikang Middle Road, Yinzhou District, Ningbo City, CN-ZJ 315000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252817

PMA Number

N/A

All Registered Proprietary Names

Power wheelchair Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) Walking Cane Mobility Scooter (BC-MS310)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2023-10-12
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-05-28
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2025-08-22
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2026-01-06

Official Correspondent

Xiaolong Wu

US Agent Details

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

Related Public Records

Same Entity

Ningbo Baichen Medical Devices 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
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Z-0036-2007	Medline Industries Inc	2	Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue

Similar Registrations

Registration Number	Establishment Name	Location
3045076265	BEIJING ORIONSTAR TECHNOLOGY CO., LTD.	Beijing, CN
3006160539	LOH ENTERPRISES, LLC	Clarks Summit, PA, US
3002667030	TUNG KENG ENTERPRISE CO., LTD.	Taichung City, TW
3043165991	HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.	SHIJIAZHUANG Hebei, CN
3036988603	SHENZHEN YATTLL INDUSTRY CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019842343. Last updated year: 2026. Please use registration number 3019842343 when referencing this establishment in official correspondence.