Kymco Foru, Model EQ35

FDA 510(k) K081980 · Besteam Technology, Inc.

Substantially Equivalent

510(k) numberK081980

Submission

Device name
Kymco Foru, Model EQ35
Applicant
Besteam Technology, Inc.
Banqiao, TW
Received
July 11, 2008
Decision date
August 4, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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Questions and answers

When was Kymco Foru, Model EQ35 cleared by the FDA?

Kymco Foru, Model EQ35 (K081980) received a 510(k) decision of Substantially Equivalent on August 4, 2008, 24 days after the submission was received.

What is the product code of K081980?

The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.