Electric Scooter (S202572J, S2060, M2089, S2050)

FDA 510(k) K252835 · Guangdong Prestige Technology Co., Ltd.

Substantially Equivalent

510(k) numberK252835

Submission

Device name
Electric Scooter (S202572J, S2060, M2089, S2050)
Applicant
Guangdong Prestige Technology Co., Ltd.
Dongguan, CN
Received
September 5, 2025
Decision date
December 23, 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

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More from Nanjing Mijo Technology Co., Ltd.

510(k)DeviceDecision
K240270Electric wheelchair (S7018)ITI · Traditional 08/27/2024SE
K240272Electric Scooter (M2085, S2091)INI · Traditional 07/16/2024SE
K230001Electric Scooter (Model: M2020)INI · Traditional 07/05/2023SE
K230615Electric Scooter (Model: S3312)INI · Traditional 05/05/2023SE

Questions and answers

When was Electric Scooter (S202572J, S2060, M2089, S2050) cleared by the FDA?

Electric Scooter (S202572J, S2060, M2089, S2050) (K252835) received a 510(k) decision of Substantially Equivalent on December 23, 2025, 109 days after the submission was received.

What is the product code of K252835?

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