Justwin Scooter, JS-3014

FDA 510(k) K032645 · Joy Ride Tech Co., Ltd.

Substantially Equivalent

510(k) numberK032645

Submission

Device name
Justwin Scooter, JS-3014
Applicant
Joy Ride Tech Co., Ltd.
Hsin-Chu City, TW
Received
August 27, 2003
Decision date
December 2, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K032643Justwin Scooter, JS-3013INI · Traditional 12/02/2003SE
K032277Justwin Scooter, Model JS-401INI · Traditional 09/24/2003SE

Questions and answers

When was Justwin Scooter, JS-3014 cleared by the FDA?

Justwin Scooter, JS-3014 (K032645) received a 510(k) decision of Substantially Equivalent on December 2, 2003, 97 days after the submission was received.

What is the product code of K032645?

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