Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006206434

FEI Number

3006206434

Entity Name

GENTEEL HOMECARE PRODUCTS CO., LTD.

City/State/Country

FOSHAN Guangdong, CN

Establishment Address

LIYU INDUSTRY AREA, DANZAO, NANHAI, FOSHAN Guangdong 528216, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Genteel Homecare Products Co., Ltd (Owner Number: 10045635)

Owner / Operator Contact Address

Liyu Industry Area, Danzao, Nanhai, Foshan, CN-GD 528216, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

patient lift Bed, Manual Grab bar Side rail Cane Long Term Care Bed and Accessories quad cane Commode, shower chair and parts Crutch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2016-04-08
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2013-12-10
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2019-12-19
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2013-12-26
IPS	Cane	Physical Medicine	Class 1	890.3075	2013-12-10
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2013-12-10
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2014-01-04
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2013-12-10
IPR	Crutch	Physical Medicine	Class 1	890.3150	2013-12-10

Official Correspondent

Jessica Pan

US Agent Details

Cancan Huang Business: OSMUNDA TECHNOLOGY CO., LTD. Email: sunny.huang@osmundacn.com Phone: (858) 3571157

Related Public Records

Same Entity

Genteel Homecare Products 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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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3010034871	VITALGO INC.	Miramar, FL, US
3001752600	USINE ROTEC INC.	BAIE-DU-FEBVRE Quebec, CA
3006795832	Hangzhou Dunli Medical Instruments Co.,Ltd	Hangzhou Zhejiang, CN
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3008951110	NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., LTD.	Rugao Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006206434. Last updated year: 2026. Please use registration number 3006206434 when referencing this establishment in official correspondence.