Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009399605

FEI Number

3009399605

Entity Name

Rolko (Zhangzhou) Wheels & Components Co., Ltd.

City/State/Country

Zhangzhou Fujian, CN

Establishment Address

No. 6-2 Yinguang Road, Gunong Farm, Changtai District, Zhangzhou Fujian 363900, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Rolko (Zhangzhou) Wheels & Components Co., Ltd. (Owner Number: 10081148)

Owner / Operator Contact Address

No. 6-2 Yinguang Road, Gunong Farm, Changtai District, Zhangzhou, CN-FJ 363900, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wheelchair Components

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2021-03-22

Official Correspondent

Angelia Huang

US Agent Details

Jill Brown Email: jill.brown@rolkona.com Phone: (641) 3516400

Related Public Records

Same Entity

Rolko (Zhangzhou) Wheels & Components Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009399605. Last updated year: 2026. Please use registration number 3009399605 when referencing this establishment in official correspondence.