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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 / July 2026 / K261396

510(k) cleared

Electric Wheelchair

Ningbo Resshidi Medical Devices Co., Ltd. · Jul 8, 2026 · K261396

FDA cleared the Electric Wheelchair from Ningbo Resshidi Medical Devices Co., Ltd. on Jul 8, 2026 under K261396, 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 Apr 29, 2026. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ningbo Resshidi Medical Devices Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261396?

K261396 is the FDA 510(k) for Electric Wheelchair, submitted by Ningbo Resshidi Medical Devices Co., Ltd.. FDA's decision date was Jul 8, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Electric Wheelchair?

Ningbo Resshidi Medical Devices Co., Ltd., based in Ningbo, is the applicant of record for K261396.

How long did the K261396 review take?

FDA received the submission on Apr 29, 2026 and issued its decision on Jul 8, 2026, 70 days later.

← All decisions in July 2026