WUYI AICHI INDUSTRY & TRADE CO., LTD.

FDA Device Registration & Listing · Wuyi City Zhejiang, CN · Registration 3032013112

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032013112
FEI Number
3032013112
Entity Name
WUYI AICHI INDUSTRY & TRADE CO., LTD.
City/State/Country
Wuyi City Zhejiang, CN
Establishment Address
Yongwu Road, Southeast Industrial Zone, Wuyi City Zhejiang 321200, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
WUYI AICHI INDUSTRY AND TRADE CO.,LTD (Owner Number: 10093729)
Owner / Operator Contact Address
SOUTHEAST INDUSTRIAL ZONE, DUAN VILLAGESHUXI STREET, WUYI CITY, JINHUA, CN-ZJ 321200, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K260237
PMA Number
N/A

All Registered Proprietary Names

Mobility Scooter (Model X-01, X-02) Mobility Scooter (X-12, X-14, X-17)

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 2025-06-29
INI Vehicle, Motorized 3-Wheeled Physical Medicine Class 2 890.3800 2026-06-12

Official Correspondent

Mr LV

US Agent Details

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

Related Public Records

Same Entity

WUYI AICHI INDUSTRY AND TRADE 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032013112. Last updated year: 2026. Please use registration number 3032013112 when referencing this establishment in official correspondence.
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