Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034729907

FEI Number

3034729907

Entity Name

FOSHAN SHENYU MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Foshan City Guangdong, CN

Establishment Address

Buliding #13, tianren Industrial Zone, leliu Town, Foshan City Guangdong 528399, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Foshan Shenyu Medical Equipment Co., Ltd. (Owner Number: 10092156)

Owner / Operator Contact Address

Buliding #13, tianren Industrial Zone, leliu Town, Foshan City, CN-GD 528399, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cane and Crutch Neck exerciser, Shoulder exerciser Bedrail, Assist pole IV pole, Stand Rollator walker, walking frame Bedside table

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPR	Crutch	Physical Medicine	Class 1	890.3150	2024-12-10
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2024-12-10
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-12-10
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-12-10
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2024-12-10
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2024-12-10

Official Correspondent

Mike You

US Agent Details

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

Related Public Records

Same Entity

Foshan 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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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3019667222	ROBINSON EXOTECH CORP	Calgary Alberta, CA
3003272910	NOVA ORTHOPEDIC AND REHABILITATION APPLIANCE INC.	Shengang Dist Taichung, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034729907. Last updated year: 2026. Please use registration number 3034729907 when referencing this establishment in official correspondence.