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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 / March 2026 / K252813

510(k) cleared

Electrical Scooter (SM4226)

Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. · Mar 17, 2026 · K252813

FDA cleared the Electrical Scooter (SM4226) from Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. on Mar 17, 2026 under K252813, 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 4, 2025. The decision came 194 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 Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252813?

K252813 is the FDA 510(k) for Electrical Scooter (SM4226), submitted by Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.. FDA's decision date was Mar 17, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Electrical Scooter (SM4226)?

Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd., based in Zhongshan, is the applicant of record for K252813.

How long did the K252813 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Mar 17, 2026, 194 days later.

← All decisions in March 2026