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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 / August 2026 / K261571

510(k) cleared

Manual Wheelchair (H008, PCK7)

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Aug 6, 2026 · K261571

FDA cleared the Manual Wheelchair (H008, PCK7) from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. on Aug 6, 2026 under K261571, 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 May 12, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K252779 (YUWELL® Electronic Blood Pressure Monitor (YE630CR)), K253228 (YUWELL® Electronic Blood Pressure Monitor (YE650AR)), K252805 (YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)).

Questions & Answers

What did FDA clear under K261571?

K261571 is the FDA 510(k) for Manual Wheelchair (H008, PCK7), submitted by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. FDA's decision date was Aug 6, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Manual Wheelchair (H008, PCK7)?

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., based in Danyang Jiangsu, is the applicant of record for K261571.

How long did the K261571 review take?

FDA received the submission on May 12, 2026 and issued its decision on Aug 6, 2026, 86 days later.

← All decisions in August 2026

Sources