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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 / K251159

510(k) cleared

Power wheelchair

Zhenjiang Assure Medical Equipment Co., Ltd. · Dec 22, 2025 · K251159

FDA cleared the Power wheelchair from Zhenjiang Assure Medical Equipment Co., Ltd. on Dec 22, 2025 under K251159, 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 15, 2025. The decision came 251 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zhenjiang Assure Medical Equipment Co., Ltd. has one other decision in the tracker over the last 12 months: K260319 (K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))).

Questions & Answers

What did FDA clear under K251159?

K251159 is the FDA 510(k) for Power wheelchair, submitted by Zhenjiang Assure Medical Equipment Co., Ltd.. FDA's decision date was Dec 22, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Power wheelchair?

Zhenjiang Assure Medical Equipment Co., Ltd., based in Zhenjiang, is the applicant of record for K251159.

How long did the K251159 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Dec 22, 2025, 251 days later.

← All decisions in December 2025

Sources