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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 / July 2026 / K261149

510(k) cleared

Electric Wheelchair (DY611A-2, DY612A-1)

Zhejiang Lumbre Electric Appliance Co., Ltd. · Jul 10, 2026 · K261149

FDA cleared the Electric Wheelchair (DY611A-2, DY612A-1) from Zhejiang Lumbre Electric Appliance Co., Ltd. on Jul 10, 2026 under K261149, a traditional 510(k). The device falls under product code ITI, Wheelchair, Powered, regulated at 21 CFR 890.3860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Apr 8, 2026. The decision came 93 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 Lumbre Electric Appliance Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261149?

K261149 is the FDA 510(k) for Electric Wheelchair (DY611A-2, DY612A-1), submitted by Zhejiang Lumbre Electric Appliance Co., Ltd.. FDA's decision date was Jul 10, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (DY611A-2, DY612A-1)?

Zhejiang Lumbre Electric Appliance Co., Ltd., based in Lishui, is the applicant of record for K261149.

How long did the K261149 review take?

FDA received the submission on Apr 8, 2026 and issued its decision on Jul 10, 2026, 93 days later.

← All decisions in July 2026