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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 / December 2025 / K252862

510(k) cleared

Electric Wheelchair (DH01126)

Foshan Dahao Medical Technology Co., Ltd. · Dec 8, 2025 · K252862

FDA cleared the Electric Wheelchair (DH01126) from Foshan Dahao Medical Technology Co., Ltd. on Dec 8, 2025 under K252862, 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 Sep 9, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Foshan Dahao Medical Technology Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K253307 (Electric wheelchair), K251458 (Electric Wheelchair (DH01168)).

Questions & Answers

What did FDA clear under K252862?

K252862 is the FDA 510(k) for Electric Wheelchair (DH01126), submitted by Foshan Dahao Medical Technology Co., Ltd.. FDA's decision date was Dec 8, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (DH01126)?

Foshan Dahao Medical Technology Co., Ltd., based in Foshan, is the applicant of record for K252862.

How long did the K252862 review take?

FDA received the submission on Sep 9, 2025 and issued its decision on Dec 8, 2025, 90 days later.

← All decisions in December 2025

Sources