Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033905189

FEI Number

3033905189

Entity Name

CHANGSHA PERFCARE MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

Room 706, Building D6, No.18 Jianshan Road, Yuelu District, Changsha Hunan 410000, CN

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

Changsha Perfcare Medical Technology Co.,LTD (Owner Number: 10091905)

Owner / Operator Contact Address

Room 706, Building D6, No.18 Jianshan Road, Yuelu District, Changsha, CN-HN 410000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Powered Wheelchair (NXN20-209) mobility scooter(C4+) Wheelchair, Powered Powered Wheelchair (NXN20-208, NXN20-211) Powered Wheelchair

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-02-14
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2025-05-29
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-11-14
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2025-02-14
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2024-11-14

Official Correspondent

Dan Tu

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Changsha Perfcare Medical 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
K853594	Vessa , Ltd.	VESSA FLIVVA	1985-09-24
K142783	Heartway Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018	Permobil, Ab Arvaltsvagen 10	2	Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007	Eagle Parts and Products	2	Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
Z-0036-2007	Medline Industries Inc	2	Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue

Similar Registrations

Registration Number	Establishment Name	Location
3045076265	BEIJING ORIONSTAR TECHNOLOGY CO., LTD.	Beijing, CN
3006160539	LOH ENTERPRISES, LLC	Clarks Summit, PA, US
3002667030	TUNG KENG ENTERPRISE CO., LTD.	Taichung City, TW
3043165991	HEBEI DANSONG MEDICAL TECHNOLOGY CO., LTD.	SHIJIAZHUANG Hebei, CN
3036988603	SHENZHEN YATTLL INDUSTRY CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033905189. Last updated year: 2026. Please use registration number 3033905189 when referencing this establishment in official correspondence.