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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 / May 2026 / K254141

510(k) cleared

Manual Wheelchair (DY01903(2))

Guangdong Dayang Medical Technology Co., Ltd. · May 21, 2026 · K254141

FDA cleared the Manual Wheelchair (DY01903(2)) from Guangdong Dayang Medical Technology Co., Ltd. on May 21, 2026 under K254141, 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 Dec 22, 2025. The decision came 150 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 Guangdong Dayang Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254141?

K254141 is the FDA 510(k) for Manual Wheelchair (DY01903(2)), submitted by Guangdong Dayang Medical Technology Co., Ltd.. FDA's decision date was May 21, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Manual Wheelchair (DY01903(2))?

Guangdong Dayang Medical Technology Co., Ltd., based in Foshan, is the applicant of record for K254141.

How long did the K254141 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on May 21, 2026, 150 days later.

← All decisions in May 2026