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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 / K261076

510(k) cleared

Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)

GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · Jun 22, 2026 · K261076

FDA cleared the Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) from GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. on Jun 22, 2026 under K261076, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Apr 1, 2026. The decision came 82 days later, inside the 90 FDA-day goal for a 510(k).

GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K261075 (Manual Wheelchair (MS01);Manual Wheelchair (MA01)).

Questions & Answers

What did FDA clear under K261076?

K261076 is the FDA 510(k) for Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02), submitted by GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.. FDA's decision date was Jun 22, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)?

GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd., based in Zhongshan, is the applicant of record for K261076.

How long did the K261076 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Jun 22, 2026, 82 days later.

← All decisions in June 2026

Sources