Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014563360

FEI Number

3014563360

Entity Name

HENYI GROUP YAOXIN CO..LTD

City/State/Country

Qidong Jiangsu, CN

Establishment Address

No. 39 Huanghai Road, High-tech Industrial Zone, Qidong City,Jiangsu Province, Qidong Jiangsu 226200, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHENYANG HENYI ENTERPRISE CO., LTD (Owner Number: 10092083)

Owner / Operator Contact Address

Pump and Valve Industrial Park, No.5 Panwu Road, Yangshigang Town, Liaozhong District, Shenyang, CN-LN 100200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bed Stool Bed Bed Rail Bed Rail

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-12-03
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2024-12-03
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use	General Hospital	Class 2	880.5100	2024-12-03
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2024-12-03
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2024-12-03

Official Correspondent

gong mingchuan

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 →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3034694766	RKS EST(SHANGHAI) CO.. LTD	Shanghai, CN

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014563360. Last updated year: 2026. Please use registration number 3014563360 when referencing this establishment in official correspondence.