Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035782854

FEI Number

3035782854

Entity Name

NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

Room 103-24, No.352 Tai'an Middle Road, No.277 Water Street, No.756 Tiantong South Road, Ningbo Zhejiang 315199, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ningbo Youhuan Automation Technology Co., Ltd. (Owner Number: 10092336)

Owner / Operator Contact Address

Room 103-24, No.352 Tai'an Middle Road, No.277 Water Street, No.756 Tiantong South Road, Ningbo, CN-ZJ 315199, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240638

PMA Number

N/A

All Registered Proprietary Names

Transfer Chair Power wheelchair: YH-E6011, YH-E6013A Power wheelchair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2025-05-28
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-05-28
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-12-24

Official Correspondent

Luhuan Xu

US Agent Details

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

Related Public Records

Same Entity

Ningbo Youhuan Automation Technology 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.

Similar Registrations

Registration Number	Establishment Name	Location
3006635905	WRIGHT PRODUCTS, INC.	DECATUR, IL, US
3016661700	SKYLLA EUROPE BV	Geleen Limburg, NL
2921578	MIZUHO ORTHOPEDIC SYSTEMS, INC.	UNION CITY, CA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3042872922	HENGXIN (VN) MEDICAL DISPOSABLES CO., LTD.	Trang Bang Tay Ninh, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035782854. Last updated year: 2026. Please use registration number 3035782854 when referencing this establishment in official correspondence.