Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020640553

FEI Number

3020640553

Entity Name

SUNTECH UK LIMITED

City/State/Country

REDHILL Surrey, GB

Establishment Address

25 ORMSIDE WAY, HOLMETHORPE INDUSTRIAL ESTATE, REDHILL Surrey RH1 2LW, GB

Establishment Type(s)

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

Owner / Operator

SunTech Uk Limited (Owner Number: 10087475)

Owner / Operator Contact Address

25 ORMSIDE WAY, HOLMETHORPE INDUSTRIAL ESTATE, REDHILL, GB-SRY RH1 2LW, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223492

PMA Number

N/A

All Registered Proprietary Names

eFOLDi Scooter, Lite

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	2023-03-03

Official Correspondent

Charles Shen

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

SunTech Uk Limited

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 3020640553. Last updated year: 2026. Please use registration number 3020640553 when referencing this establishment in official correspondence.