WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / February 2026 / K253631

510(k) cleared

Mobility Scooter (CL-Q3, CL-Q4)

Zhejiang Wei Ling New Energy Technology Co., Ltd. · Feb 23, 2026 · K253631

FDA cleared the Mobility Scooter (CL-Q3, CL-Q4) from Zhejiang Wei Ling New Energy Technology Co., Ltd. on Feb 23, 2026 under K253631, 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 Nov 19, 2025. The decision came 96 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 Zhejiang Wei Ling New Energy Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253631?

K253631 is the FDA 510(k) for Mobility Scooter (CL-Q3, CL-Q4), submitted by Zhejiang Wei Ling New Energy Technology Co., Ltd.. FDA's decision date was Feb 23, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility Scooter (CL-Q3, CL-Q4)?

Zhejiang Wei Ling New Energy Technology Co., Ltd., based in Taizhou, is the applicant of record for K253631.

How long did the K253631 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Feb 23, 2026, 96 days later.

← All decisions in February 2026