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 / June 2026 / K260937

510(k) cleared

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)

Shanghai Waylong Intelligent Technology Co.,Ltd · Jun 24, 2026 · K260937

FDA cleared the Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) from Shanghai Waylong Intelligent Technology Co.,Ltd on Jun 24, 2026 under K260937, 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 Mar 20, 2026. 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 Shanghai Waylong Intelligent Technology Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260937?

K260937 is the FDA 510(k) for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK), submitted by Shanghai Waylong Intelligent Technology Co.,Ltd. FDA's decision date was Jun 24, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)?

Shanghai Waylong Intelligent Technology Co.,Ltd, based in Shanghai, is the applicant of record for K260937.

How long did the K260937 review take?

FDA received the submission on Mar 20, 2026 and issued its decision on Jun 24, 2026, 96 days later.

← All decisions in June 2026