Kymco ForU EQ40
by Kwang Yang Motor Co., Ltd 510(k)
Active
510(k) K081133
Overview
The Kymco ForU EQ40 is a motorized three-wheeled vehicle, classified under FDA regulation 21 CFR 890.3800. It is designed as a lightweight, three-wheeled motorized transport device intended for personal mobility and utility tasks, offering a balance of maneuverability and stability for users.
This device is supplied as a reusable, non-medical product and is not intended for clinical or medical use. It is regulated under FDA 510(k) clearance (K081133) as substantially equivalent to predicate devices, with no third-party certification required. The vehicle is intended for general use in non-clinical settings and does not carry MRI safety or sterility classifications. Storage and maintenance follow standard vehicle guidelines.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081133 | Date10 Jun 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Kymco Foru, Model EQ40
- 510(k) Number
- FDA Product Code
- INI
- FDA applicant
- Kwang Yang Motor Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
COMPANY KWANG YANG MOTOR CO., LTD.
Other devices from Kwang Yang Motor Co., Ltd
Questions
Is the Kymco ForU EQ40 intended for clinical or medical use, or is it designed for general personal mobility and utility tasks?
The Kymco ForU EQ40 is explicitly not intended for clinical or medical use. It is classified under FDA regulation 21 CFR 890.3800 as a motorized three-wheeled vehicle for personal mobility and utility tasks, offering maneuverability and stability in non-clinical settings. Its regulatory pathway (FDA 510(k) clearance) and lack of sterility or MRI safety classifications further confirm its general-use purpose.
How is the Kymco ForU EQ40 supplied, and what does its reusable status mean for maintenance?
The Kymco ForU EQ40 is supplied as a reusable product, meaning it is not single-use. This implies it requires standard vehicle maintenance—such as periodic inspections, tire checks, battery care, and mechanical servicing—to ensure safe and reliable operation. Maintenance guidelines follow typical motorized vehicle protocols, as outlined in the device description.
What regulatory route was taken for FDA clearance of the Kymco ForU EQ40, and what does this imply about third-party certification?
The Kymco ForU EQ40 received FDA clearance via a Traditional 510(k) process (K081133), determined to be substantially equivalent to predicate devices. The third-party certification flag is marked as ‘N’ (no), meaning no external certification (e.g., ISO, ANSI) was required for this clearance. This aligns with its classification as a non-medical, general-use motorized vehicle.
Are there multiple model variants or sizes available for the Kymco ForU EQ40, and how would one identify them?
The provided data lists multiple registration numbers (e.g., 3033905189, 3012604975, etc.) under the Kymco ForU EQ40, which may correspond to different variants or configurations (e.g., chassis, engine specs, or minor design updates). However, the data does not specify exact differences between these variants. To confirm available sizes or models, you would need to consult the manufacturer’s catalog or contact Kwang Yang Motor Co., Ltd. directly, as these details are not explicitly outlined in the regulatory submission.