Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030233125

FEI Number

3030233125

Entity Name

CHANGZHOU LANGCHENG INTELLIGENT TECHNOLOGY CO., LTD

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No.2, Tenglong Road, Changzhou West Taihu Lake Science and Technology Industrial Park, Wujin District, Changzhou City Jiangsu 213100, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Changzhou Langcheng Intelligent Technology Co., Ltd (Owner Number: 10092368)

Owner / Operator Contact Address

No.2, Tenglong Road, Changzhou West Taihu Lake Science and Technology Industrial Park, Wujin District, Changzhou City, CN-JS 213100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electric hospital bed/Electric bed Transfer Lifter Machine, Shifting machine Rollator, Walking aids, Walker, Knee Walker Transfer Lifter Machine, Shifting machine, Patient Lift Manual hospital bed/Manual bed Crutch, Walking stick/cane Bath Chair Manual Wheelchair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-12-29
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2025-04-02
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2024-12-29
FRZ	Device, Patient Transfer, Powered	General Hospital	Class 2	880.6775	2025-06-25
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2024-12-29
IPR	Crutch	Physical Medicine	Class 1	890.3150	2024-12-29
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2025-04-02
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2024-12-29

Official Correspondent

Hou Ying

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Changzhou Langcheng Intelligent Technology 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
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
Z-0011-2015	Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056	1	Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030233125. Last updated year: 2026. Please use registration number 3030233125 when referencing this establishment in official correspondence.