Ruike, Model 3411

FDA 510(k) K062646 · Shanghai Ruike Sports Goods Co., Ltd.

Substantially Equivalent

510(k) numberK062646

Submission

Device name
Ruike, Model 3411
Applicant
Shanghai Ruike Sports Goods Co., Ltd.
Banqiao, TW
Received
September 4, 2006
Decision date
February 5, 2007
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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More from Nanjing Mijo Technology Co., Ltd.

510(k)DeviceDecision
K070501Ruike 3421 Powered WheelchairITI · Traditional 03/22/2007SE
K062645Ruike, Model 3431INI · Traditional 12/19/2006SE
K062676Ruike, Model 3331INI · Traditional 12/14/2006SE

Questions and answers

When was Ruike, Model 3411 cleared by the FDA?

Ruike, Model 3411 (K062646) received a 510(k) decision of Substantially Equivalent on February 5, 2007, 154 days after the submission was received.

What is the product code of K062646?

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