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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K252835

510(k) cleared

Electric Scooter (S202572J, S2060, M2089, S2050)

Guangdong Prestige Technology Co., Ltd. · Dec 23, 2025 · K252835

FDA cleared the Electric Scooter (S202572J, S2060, M2089, S2050) from Guangdong Prestige Technology Co., Ltd. on Dec 23, 2025 under K252835, a traditional 510(k). The device falls under product code INI, Vehicle, Motorized 3-Wheeled, regulated at 21 CFR 890.3800 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Sep 5, 2025. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Guangdong Prestige Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252835?

K252835 is the FDA 510(k) for Electric Scooter (S202572J, S2060, M2089, S2050), submitted by Guangdong Prestige Technology Co., Ltd.. FDA's decision date was Dec 23, 2025, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Electric Scooter (S202572J, S2060, M2089, S2050)?

Guangdong Prestige Technology Co., Ltd., based in Dongguan, is the applicant of record for K252835.

How long did the K252835 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Dec 23, 2025, 109 days later.

← All decisions in December 2025