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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 / March 2026 / K253980

510(k) cleared

Electrically Powered Wheelchair (Model YC-01)

Yurob Rehabilitation Medical Co., Ltd. · Mar 27, 2026 · K253980

FDA cleared the Electrically Powered Wheelchair (Model YC-01) from Yurob Rehabilitation Medical Co., Ltd. on Mar 27, 2026 under K253980, 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 Dec 12, 2025. The decision came 105 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Yurob Rehabilitation Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K253600 (Scooter (YD-03)).

Questions & Answers

What did FDA clear under K253980?

K253980 is the FDA 510(k) for Electrically Powered Wheelchair (Model YC-01), submitted by Yurob Rehabilitation Medical Co., Ltd.. FDA's decision date was Mar 27, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electrically Powered Wheelchair (Model YC-01)?

Yurob Rehabilitation Medical Co., Ltd., based in Kunshan, is the applicant of record for K253980.

How long did the K253980 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Mar 27, 2026, 105 days later.

← All decisions in March 2026

Sources