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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 / K253599

510(k) cleared

Electric Wheelchair (W-A807, W-A807L)

Ningbo Shenyu Medical Equipment Co.,Ltd · Feb 17, 2026 · K253599

FDA cleared the Electric Wheelchair (W-A807, W-A807L) from Ningbo Shenyu Medical Equipment Co.,Ltd on Feb 17, 2026 under K253599, 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 18, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ningbo Shenyu Medical Equipment Co.,Ltd has one other decision in the tracker over the last 12 months: K252517 (Manual Wheelchair (SYIV100A008)).

Questions & Answers

What did FDA clear under K253599?

K253599 is the FDA 510(k) for Electric Wheelchair (W-A807, W-A807L), submitted by Ningbo Shenyu Medical Equipment Co.,Ltd. FDA's decision date was Feb 17, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (W-A807, W-A807L)?

Ningbo Shenyu Medical Equipment Co.,Ltd, based in Yuyao, is the applicant of record for K253599.

How long did the K253599 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Feb 17, 2026, 91 days later.

← All decisions in February 2026

Sources