C.T.M Mobility Scooter

FDA 510(k) K181344 · Chien TI Enterprise Co., Ltd.

Substantially Equivalent

510(k) numberK181344

Submission

Device name
C.T.M Mobility Scooter
Applicant
Chien TI Enterprise Co., Ltd.
New Taipei City, Hsin Chuang District, CN
Received
May 21, 2018
Decision date
December 14, 2018
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

Other 510(k)s with product code INI

510(k)DeviceApplicantDecision
K260176Mobility Scooter (W3483, W3483A)INI · Traditional Zhejiang Innuovo Rehabilitation Devices Co.,Ltd08/10/2026SE
K260094Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional Zhejiang Innuovo Rehabilitation Devices Co.,Ltd08/10/2026SE
K261232IERO Mobility Scooter (IERO-01)INI · Traditional Jochu Technology Co., Ltd.07/14/2026SE
K261163Mobility Scooter (R200)INI · Traditional Yongkang Ruihe Metal Product Co., Ltd.07/07/2026SE
K253257Virgo Mobility Scooter (Virgo-D,Virgo-F)INI · Traditional Jiangsu Intco Medical Products Co., Ltd.06/08/2026SE
K253600Scooter (YD-03)INI · Traditional Yurob Rehabilitation Medical Co., Ltd.06/03/2026SE
K260717Mobility Scooter (Air Carbon)INI · Traditional Suzhou Sweetrich Vehicle Industry Technology…05/20/2026SE
K260237Mobility Scooter (X-12, X-14, X-17)INI · Traditional Wuyi Aichi Industry and Trade Co., Ltd.04/22/2026SE
K252813Electrical Scooter (SM4226)INI · Traditional Lerado Zhongshan Peaceful Cove Business Trading…03/17/2026SE
K253936Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional Nanjing Mijo Technology Co., Ltd.03/12/2026SE

More from Nanjing Mijo Technology Co., Ltd.

510(k)DeviceDecision
K192885C.T.M. Mobility Scooter HS-268INI · Traditional 12/09/2019SE
K162952C.T.M. Mobility ScooterINI · Traditional 05/03/2017SE

Questions and answers

When was C.T.M Mobility Scooter cleared by the FDA?

C.T.M Mobility Scooter (K181344) received a 510(k) decision of Substantially Equivalent on December 14, 2018, 207 days after the submission was received.

What is the product code of K181344?

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