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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 / June 2026 / K260335

510(k) cleared

Electric Wheelchair (S500-6)

Zhongshan Sulenz Intelligent Technology Co., Ltd. · Jun 15, 2026 · K260335

FDA cleared the Electric Wheelchair (S500-6) from Zhongshan Sulenz Intelligent Technology Co., Ltd. on Jun 15, 2026 under K260335, 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 Feb 2, 2026. The decision came 133 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 Zhongshan Sulenz Intelligent Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260335?

K260335 is the FDA 510(k) for Electric Wheelchair (S500-6), submitted by Zhongshan Sulenz Intelligent Technology Co., Ltd.. FDA's decision date was Jun 15, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (S500-6)?

Zhongshan Sulenz Intelligent Technology Co., Ltd., based in Zhongshan, is the applicant of record for K260335.

How long did the K260335 review take?

FDA received the submission on Feb 2, 2026 and issued its decision on Jun 15, 2026, 133 days later.

← All decisions in June 2026