Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007689746

FEI Number

3007689746

Entity Name

SHENYANG HENYI ENTERPRISE CO., LTD

City/State/Country

Shenyang Liaoning, CN

Establishment Address

Pump and Valve Industrial Park, No.5 Panwu Road, Yangshigang Town, Liaozhong District, Shenyang Liaoning 110200, 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

Shenyang Henyi Enterprise Co Ltd (Owner Number: 10028767)

Owner / Operator Contact Address

No.386-3 Qingnian ST., Heping Dis., Shenyang, CN-LN 110004, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nurse bed 15001ABV BED RAILS FULL LENGHT Foot Stool with Handrail Foot Stool Bariatric Foot Stool with Handrail Home Bed Assist Handle with Legs that Reach the Floor 13023SV19 BASE TIP COVER BED, AC-POWERED ADJUSTABLE HOSPITAL Adjustable Height, Parallel to the Tub Oxygen Cylinder Stand Trapeze Patient Lifts 13240 Bariatric Battery PoweredPatient Lift. 13242 Bariatric Powered Patient Lift with RechargeableRemovable Battery; 13

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	2024-05-06
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2024-01-12
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2017-08-02
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2024-01-12
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2019-03-04
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2017-08-02
PCM	Portable Liquid Oxygen Unit Stand	Physical Medicine	Class 1	890.5050	2017-08-02
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2009-03-04

Official Correspondent

Leo Gong

US Agent Details

Archibald A. Simm Email: seven7hiyi@gmail.com Phone: (713) 9074179

Related Public Records

Same Entity

Shenyang Henyi Enterprise 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
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
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

Similar Registrations

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9616091	INVAMEX S.DE R.L. DE C.V.	REYNOSA Tamaulipas, MX
3003749961	INDUSTRIAS METALICAS LOS PINOS SA	ITAGUI Antioquia, CO
3030019986	QuantMed LifeTech (Shenzhen) Co., Ltd.	ShenzhenCity Guangdong, CN
3009265647	Kunshan Hi-Fortune Health Products Co., Ltd.	Kunshan City, Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007689746. Last updated year: 2026. Please use registration number 3007689746 when referencing this establishment in official correspondence.