Kymco Foru, Model EQ40
FDA 510(k) K081133 · Kwang Yang Motor Co., Ltd.
510(k) numberK081133
Submission
- Device name
- Kymco Foru, Model EQ40
- Applicant
- Kwang Yang Motor Co., Ltd.
Banqiao, TW - Received
- April 21, 2008
- Decision date
- June 10, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
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| K253936 | Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional | Nanjing Mijo Technology Co., Ltd. | 03/12/2026SE |
More from Nanjing Mijo Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K163201 | KYMCO EQ10D ScooterINI · Traditional | 03/16/2017SE |
| K130940 | Kymco EQ20C ScooterINI · Traditional | 10/07/2013SE |
| K082901 | Kymco Foru, Model EQ20INI · Traditional | 10/28/2008SE |
| K082900 | Kymco Foru, Model EQ10INI · Traditional | 10/28/2008SE |
| K072630 | Foru, Model EQ30INI · Traditional | 10/03/2007SE |
| K072027 | Foru KV10HBITI · Traditional | 08/20/2007SE |
Questions and answers
When was Kymco Foru, Model EQ40 cleared by the FDA?
Kymco Foru, Model EQ40 (K081133) received a 510(k) decision of Substantially Equivalent on June 10, 2008, 50 days after the submission was received.
What is the product code of K081133?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.