WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / January 2026 / K251458

510(k) cleared

Electric Wheelchair (DH01168)

Foshan Dahao Medical Technology Co., Ltd. · Jan 15, 2026 · K251458

FDA cleared the Electric Wheelchair (DH01168) from Foshan Dahao Medical Technology Co., Ltd. on Jan 15, 2026 under K251458, 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 May 12, 2025. The decision came 248 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: K253307 (Electric wheelchair), K252862 (Electric Wheelchair (DH01126)).

Questions & Answers

What did FDA clear under K251458?

K251458 is the FDA 510(k) for Electric Wheelchair (DH01168), submitted by Foshan Dahao Medical Technology Co., Ltd.. FDA's decision date was Jan 15, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair (DH01168)?

Foshan Dahao Medical Technology Co., Ltd., based in Foshan, is the applicant of record for K251458.

How long did the K251458 review take?

FDA received the submission on May 12, 2025 and issued its decision on Jan 15, 2026, 248 days later.

← All decisions in January 2026

Sources