Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044425292

FEI Number

3044425292

Entity Name

SHENZHEN ZHIMAHUAERKAI TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Rm.602, Bldg. F1, Tcl Science Park #1001 Zhongshan Garden Rd, Shuguang Community, Xili St., Nanshan District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Zhimahuaerkai Technology Co., Ltd. (Owner Number: 10095489)

Owner / Operator Contact Address

Rm.602, Bldg. F1, Tcl Science Park, #1001 Zhongshan Garden Rd., Shuguang Community, Xili St., Nanshan District, Shenzhen, CN-NOTA 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253707

PMA Number

N/A

All Registered Proprietary Names

Mobility Scooter (S3) Electric wheelchair (W1, W3)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2026-03-19
ITI	Wheelchair, Powered	Physical Medicine	Class 2	890.3860	2026-03-19

Official Correspondent

Xianwei Zhang

US Agent Details

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

Related Public Records

Same Entity

Shenzhen Zhimahuaerkai 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-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
Z-0037-2007	Medline Industries Inc	2	Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807650 - red and MDS807650B - blue
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044425292. Last updated year: 2026. Please use registration number 3044425292 when referencing this establishment in official correspondence.