Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033882216

FEI Number

3033882216

Entity Name

JIANGMEN ELITE MEDICAL EQUIPMENT LTD

City/State/Country

Jiangmen Guangdong, CN

Establishment Address

Building 14, No. 185, Jianshe 3rd Road, Pengjiang District, Jiangmen Guangdong 529000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JIANGMEN ELITE MEDICAL EQUIPMENT LTD (Owner Number: 10091841)

Owner / Operator Contact Address

Building 14, No. 185, Jianshe 3rd Road, Pengjiang District, Jiangmen, CN-GD 529000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trapeze Bar and Base HOFFBEDTRAPEZ, HOFF300LBFST AIR-7TP, AIR-LP1, AIR-4TP Electric Bed AIR-4XXLOW, AIR-3ABG, AIR-36XE, AIR-42XX HOFF1000, HOFF750SCALE, HOFF650, HOFF500, HOFF750 AIR-11HL Non-AC-Powered Patient Lift AIR-15FL,AIR10ST,STR500LB,STR500PB,STR600LB,STR600PB,STS500,STS600 AC-Powered Patient Lift

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2024-11-06
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-11-06
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2024-11-06
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2024-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

JIANGMEN ELITE MEDICAL EQUIPMENT 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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

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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3010101089	WUYI COMON MEDICAL APPLIANCES CO., LTD.	Jinhua City Zhejiang, CN
3009512503	MEDSOURCE FACTORY,INC.	CHANGZHOU Jiangsu, CN
3010363540	JIANGYIN CITY RUIRUN CLOTHING CO., LTD.	Jiangyin City Jiangsu, CN
3038279528	3H MEDICAL (THAILAND) CO., LTD.	Nong Yai District Chon Buri, TH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033882216. Last updated year: 2026. Please use registration number 3033882216 when referencing this establishment in official correspondence.