Scooter (YD-03)

FDA 510(k) K253600 · Yurob Rehabilitation Medical Co., Ltd.

Substantially Equivalent

510(k) numberK253600

Submission

Device name
Scooter (YD-03)
Applicant
Yurob Rehabilitation Medical Co., Ltd.
Kunshan, CN
Received
November 18, 2025
Decision date
June 3, 2026
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
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
K253631Mobility Scooter (CL-Q3, CL-Q4)INI · Traditional Zhejiang Wei Ling New Energy Technology Co., Ltd.02/23/2026SE

More from Zhejiang Wei Ling New Energy Technology Co., Ltd.

510(k)DeviceDecision
K253980Electrically Powered Wheelchair (Model YC-01)ITI · Traditional 03/27/2026SE
K232193Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)ITI · Traditional 09/22/2023SE

Questions and answers

When was Scooter (YD-03) cleared by the FDA?

Scooter (YD-03) (K253600) received a 510(k) decision of Substantially Equivalent on June 3, 2026, 197 days after the submission was received.

What is the product code of K253600?

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