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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 / February 2026 / K253789

510(k) cleared

Electric wheelchair

Zhejiang Yikang Medical Technology Co., Ltd. · Feb 25, 2026 · K253789

FDA cleared the Electric wheelchair from Zhejiang Yikang Medical Technology Co., Ltd. on Feb 25, 2026 under K253789, 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 Nov 28, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zhejiang Yikang Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253789?

K253789 is the FDA 510(k) for Electric wheelchair, submitted by Zhejiang Yikang Medical Technology Co., Ltd.. FDA's decision date was Feb 25, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric wheelchair?

Zhejiang Yikang Medical Technology Co., Ltd., based in Lishui, is the applicant of record for K253789.

How long did the K253789 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Feb 25, 2026, 89 days later.

← All decisions in February 2026