Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039857114

FEI Number

3039857114

Entity Name

NANJING KANGNI SMART TECHNOLOGY CO.,LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

No.11 Hengjing Rd. Economic & Technological Development Zone, Nanjing Jiangsu 21146, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Nanjing Kangni Smart Technology Co.,Ltd. (Owner Number: 10094531)

Owner / Operator Contact Address

No.11 Hengjing Rd. Economic & Technological Development Zone, Nanjing, CN-NOTA 21146, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252502

PMA Number

N/A

All Registered Proprietary Names

Folding Mobility 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	2025-12-05

Official Correspondent

Huilin Yu

US Agent Details

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

Related Public Records

Same Entity

Nanjing Kangni Smart 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039857114. Last updated year: 2026. Please use registration number 3039857114 when referencing this establishment in official correspondence.