Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004168774

FEI Number

3004168774

Entity Name

XIAMEN WORLD GEAR SPORTS GOODS CO., LTD

City/State/Country

XIAMEN Fujian, CN

Establishment Address

27-29 NORTH 2ND ROAD, XIAMEN Fujian 361022, CN

Establishment Type(s)

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

Owner / Operator

XIAMEN WORLD GEAR SPORTS GOODS CO., LTD (Owner Number: 9058930)

Owner / Operator Contact Address

27-29 NORTH 2ND ROAD, --, XIAMEN, CN-FJ 361022, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G53 Panacea6300/0-58625 PrimeCare Bed Model 750 PrimePlus2002 Panacea6500/0-99545 BAR5301IVC PrimePlus 1752 PLTCAR PLTCDR PLTCAB PrimeCare Bed Model 703 PrimeCare Bed Model 903 5301 LOW PrimeCare Bed Model 503 5301 IVC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2026-04-30
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2009-07-30
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2011-05-04
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2024-06-23
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2009-07-30

Official Correspondent

LUCA TONARINI

US Agent Details

Michael Gayetsky Email: MichaelGayetsky@hotmail.com Phone: (330) 3987476

Related Public Records

Same Entity

XIAMEN WORLD GEAR SPORTS GOODS 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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02
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

Similar Registrations

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3018013882	ARKIETECH ENGINEERING CO.,	Tainan City, TW
3004860474	HELTON INC	Morrison, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004168774. Last updated year: 2026. Please use registration number 3004168774 when referencing this establishment in official correspondence.