Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032597250

FEI Number

3032597250

Entity Name

FUJIAN PACIFIC MEDICAL MANUFACTURING CO., LTD.

City/State/Country

Yunxiao County Fujian, CN

Establishment Address

No. 09-1 Yishu Avenue, Yunxiang Industrial Park, Yunxiao County, Yunxiao County Fujian 363300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fujian Pacific Medical Manufacturing Co., Ltd. (Owner Number: 10091384)

Owner / Operator Contact Address

No. 09-1 Yishu Avenue, Yunxiang Industrial Park, Yunxiao County, Yunxiao County, CN-FJ 363300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WHEELCHAIR, MECHANICAL BED, AC-POWERED ADJUSTABLE HOSPITAL CHAIR AND TABLE, MEDICAL WHEELCHAIR, MECHANICAL BED, MANUAL ATTACHMENT, COMMODE, WHEELCHAIR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2024-10-16
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-10-16
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2024-09-13
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2024-10-16
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2024-10-16
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2024-10-16

Official Correspondent

Karen Yang

US Agent Details

Carlton Chang Email: carlton@integrity-united.com Phone: (714) 4852206

Related Public Records

Same Entity

Fujian Pacific Medical Manufacturing 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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
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 3032597250. Last updated year: 2026. Please use registration number 3032597250 when referencing this establishment in official correspondence.