Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015726735

FEI Number

3015726735

Entity Name

TIANJIN KEPLER VEHICLE INDUSTRY CO.,LTD

City/State/Country

Tianjin, CN

Establishment Address

Xinmin road, west area of economic and technological development zone, Tianjin 300462, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tianjin Kepler Vehicle Industry Co.,Ltd (Owner Number: 10060923)

Owner / Operator Contact Address

Xinmin road, west area of economic and technological development zone, Tianjin, CN-TJ 300462, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041025

PMA Number

N/A

All Registered Proprietary Names

scooter scooter

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	2019-10-28
INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	Class 2	890.3800	2019-07-15

Official Correspondent

haijun Hao

US Agent Details

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

Related Public Records

Same Entity

Tianjin Kepler Vehicle Industry 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 3015726735. Last updated year: 2026. Please use registration number 3015726735 when referencing this establishment in official correspondence.