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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 / September 2025 / K251891

510(k) cleared

Electric Wheelchair (GY-E001)

Shandong Guyue Healthcare Appliance Co., Ltd. · Sep 9, 2025 · K251891

FDA cleared the Electric Wheelchair (GY-E001) from Shandong Guyue Healthcare Appliance Co., Ltd. on Sep 9, 2025 under K251891, 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 Jun 20, 2025. The decision came 81 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shandong Guyue Healthcare Appliance Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251891?

K251891 is the FDA 510(k) for Electric Wheelchair (GY-E001), submitted by Shandong Guyue Healthcare Appliance Co., Ltd.. FDA's decision date was Sep 9, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (GY-E001)?

Shandong Guyue Healthcare Appliance Co., Ltd., based in Binzhou, is the applicant of record for K251891.

How long did the K251891 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Sep 9, 2025, 81 days later.

← All decisions in September 2025