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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 / April 2026 / K260237

510(k) cleared

Mobility Scooter (X-12, X-14, X-17)

Wuyi Aichi Industry and Trade Co., Ltd. · Apr 22, 2026 · K260237

FDA cleared the Mobility Scooter (X-12, X-14, X-17) from Wuyi Aichi Industry and Trade Co., Ltd. on Apr 22, 2026 under K260237, 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 Jan 26, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Wuyi Aichi Industry and Trade Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260237?

K260237 is the FDA 510(k) for Mobility Scooter (X-12, X-14, X-17), submitted by Wuyi Aichi Industry and Trade Co., Ltd.. FDA's decision date was Apr 22, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility Scooter (X-12, X-14, X-17)?

Wuyi Aichi Industry and Trade Co., Ltd., based in Jinhua, is the applicant of record for K260237.

How long did the K260237 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Apr 22, 2026, 86 days later.

← All decisions in April 2026