VCS, Model S4T

FDA 510(k) K052558 · Cycling and Health Tech. Industry R&D Center/Chc

Substantially Equivalent

510(k) numberK052558

Submission

Device name
VCS, Model S4T
Applicant
Cycling and Health Tech. Industry R&D Center/Chc
Taichung, TW
Received
September 16, 2005
Decision date
October 27, 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 VCS, Model S4T cleared by the FDA?

VCS, Model S4T (K052558) received a 510(k) decision of Substantially Equivalent on October 27, 2005, 41 days after the submission was received.

What is the product code of K052558?

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