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 / June 2026 / K260642

510(k) cleared

Manual Wheelchair (LW01108)

Anhui Longway Medical Technology Co., Ltd. · Jun 2, 2026 · K260642

FDA cleared the Manual Wheelchair (LW01108) from Anhui Longway Medical Technology Co., Ltd. on Jun 2, 2026 under K260642, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Feb 27, 2026. The decision came 95 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Anhui Longway Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260642?

K260642 is the FDA 510(k) for Manual Wheelchair (LW01108), submitted by Anhui Longway Medical Technology Co., Ltd.. FDA's decision date was Jun 2, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the Manual Wheelchair (LW01108)?

Anhui Longway Medical Technology Co., Ltd., based in Mingguang, is the applicant of record for K260642.

How long did the K260642 review take?

FDA received the submission on Feb 27, 2026 and issued its decision on Jun 2, 2026, 95 days later.

← All decisions in June 2026