Landlex Model S400X

FDA 510(k) K050793 · Cycling and Health Tech. Industry R&D Center

Substantially Equivalent

510(k) numberK050793

Submission

Device name
Landlex Model S400X
Applicant
Cycling and Health Tech. Industry R&D Center
Taichung, TW
Received
March 28, 2005
Decision date
July 7, 2005
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 Landlex Model S400X cleared by the FDA?

Landlex Model S400X (K050793) received a 510(k) decision of Substantially Equivalent on July 7, 2005, 101 days after the submission was received.

What is the product code of K050793?

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