Powered Mobility Scooter (PMS105, GUT177, GCAT047)

FDA 510(k) K252590 · Intradin (Shanghai) Machinery Co., Ltd.

Substantially Equivalent

510(k) numberK252590

Submission

Device name
Powered Mobility Scooter (PMS105, GUT177, GCAT047)
Applicant
Intradin (Shanghai) Machinery Co., Ltd.
Shanghai, CN
Received
August 15, 2025
Decision date
November 21, 2025
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
K243970Portable WheelchairITI · Traditional 03/07/2025SE
K250027Powered Mobility ScooterINI · Special 02/21/2025SE
K232692Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)INI · Traditional 09/05/2024SE

Questions and answers

When was Powered Mobility Scooter (PMS105, GUT177, GCAT047) cleared by the FDA?

Powered Mobility Scooter (PMS105, GUT177, GCAT047) (K252590) received a 510(k) decision of Substantially Equivalent on November 21, 2025, 98 days after the submission was received.

What is the product code of K252590?

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