Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000252066

FEI Number

1000252066

Entity Name

Shin-I Medical Manufacturing Co. Ltd.

City/State/Country

Taoyuan, TW

Establishment Address

No.3, Hai-Ping Road, Kwei Shen, Taoyuan 33748, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shin-I Medical Manufacturing Co. Ltd. (Owner Number: 10048609)

Owner / Operator Contact Address

No.3, Hai-Ping Road, Kwei Shen, Taoyuan City, TW-TAO 33348, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Mechanical Wheelchair Commode Wheelchair Walker and Rollator Cane Powered Hospital Bed Air Mattress Powered Patient Lift

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2015-02-10
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2015-02-10
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2015-02-10
IPS	Cane	Physical Medicine	Class 1	890.3075	2015-02-10
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2015-02-10
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2016-03-25
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2021-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Shin-I 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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000252066. Last updated year: 2026. Please use registration number 1000252066 when referencing this establishment in official correspondence.