Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010461764

FEI Number

3010461764

Entity Name

NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Yuyao Zhejiang, CN

Establishment Address

West of Tanjialing Road, Yuyao Zhejiang 315408, CN

Establishment Type(s)

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

Owner / Operator

Ningbo Shenyu Medical Equipment Co., Ltd. (Owner Number: 10045006)

Owner / Operator Contact Address

West of Tanjialing Road, Yuyao, CN-ZJ 315408, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252517

PMA Number

N/A

All Registered Proprietary Names

Table, Mechanical Table Crutches Manual Wheelchair (A006) Wheel chairs Electric Wheelchair (W-A807, W-A807L) Transport Chairs Manual Wheelchair Canes Walkers, Rollators Manual Wheelchair (SYIV100A008)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2015-02-11
IPR	Crutch	Physical Medicine	Class 1	890.3150	2013-09-11
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2023-07-09
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2013-09-11
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-25
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2013-09-11
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2021-12-12
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2013-09-11
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2013-09-11
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-12-17

Official Correspondent

Yonghui Rong

US Agent Details

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

Related Public Records

Same Entity

Ningbo Shenyu Medical Equipment 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
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-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.

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3007309323	ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD	ZHENJIANG CITY Jiangsu, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010461764. Last updated year: 2026. Please use registration number 3010461764 when referencing this establishment in official correspondence.