Bewell, Model SC 20

FDA 510(k) K043326 · Cycling and Health Tech. Industry R&D Center

Substantially Equivalent

510(k) numberK043326

Submission

Device name
Bewell, Model SC 20
Applicant
Cycling and Health Tech. Industry R&D Center
Taichung, TW
Received
December 2, 2004
Decision date
January 26, 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 Bewell, Model SC 20 cleared by the FDA?

Bewell, Model SC 20 (K043326) received a 510(k) decision of Substantially Equivalent on January 26, 2005, 55 days after the submission was received.

What is the product code of K043326?

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