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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 / March 2026 / K253307

510(k) cleared

Electric wheelchair

Foshan Dahao Medical Technology Co., Ltd. · Mar 27, 2026 · K253307

FDA cleared the Electric wheelchair from Foshan Dahao Medical Technology Co., Ltd. on Mar 27, 2026 under K253307, 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 29, 2025. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Foshan Dahao Medical Technology Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K251458 (Electric Wheelchair (DH01168)), K252862 (Electric Wheelchair (DH01126)).

Questions & Answers

What did FDA clear under K253307?

K253307 is the FDA 510(k) for Electric wheelchair, submitted by Foshan Dahao Medical Technology Co., Ltd.. FDA's decision date was Mar 27, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric wheelchair?

Foshan Dahao Medical Technology Co., Ltd., based in Foshan, is the applicant of record for K253307.

How long did the K253307 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Mar 27, 2026, 179 days later.

← All decisions in March 2026

Sources