Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016733848

FEI Number

3016733848

Entity Name

Guangdong Zhanyuan Smart Science and Technology Co. Ltd.

City/State/Country

Dalang Town, Dongguan City Guangdong, CN

Establishment Address

Room 301 Building 3, No. 60 Fumin South Road, Dalang Town, Dongguan City Guangdong 523796, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Guangdong Zhanyuan Smart Science and Technology Co. Ltd (Owner Number: 10064025)

Owner / Operator Contact Address

Room 301 Building 3, No. 60 Fumin South Rd, Dalang Town, Dongguan City, CN-GD 523796, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041025

PMA Number

N/A

All Registered Proprietary Names

GB120A

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	2020-03-23

Official Correspondent

Mark Mrugal

US Agent Details

Mark Mrugal Business: Golden Technologies Inc. Email: mmrugal@goldentech.com Phone: (570) 4517477

Related Public Records

Same Entity

Guangdong Zhanyuan Smart Science and Technology Co. Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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

Similar Registrations

Registration Number	Establishment Name	Location
3043153502	ZHEJIANG TAOTAO VEHICLE CO.,LTD	Lishui City Zhejiang, CN
3008841035	Guangdong Prestige Technology Co., Ltd.	Dongguan Guangdong, CN
9616873	WU'S TECH CO., LTD.	Hsin-Chu City Hsinchu, TW
3004594214	Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.	Zhongshan City Guangdong, CN
2531465	PRIDE MOBILITY PRODUCTS CORP.	DURYEA, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016733848. Last updated year: 2026. Please use registration number 3016733848 when referencing this establishment in official correspondence.