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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 / October 2025 / K251565

510(k) cleared

Wheelchair (N817)

Zhejiang Topwe Tools Manufacturing Co.,Ltd · Oct 6, 2025 · K251565

FDA cleared the Wheelchair (N817) from Zhejiang Topwe Tools Manufacturing Co.,Ltd on Oct 6, 2025 under K251565, 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 22, 2025. The decision came 137 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 Zhejiang Topwe Tools Manufacturing Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251565?

K251565 is the FDA 510(k) for Wheelchair (N817), submitted by Zhejiang Topwe Tools Manufacturing Co.,Ltd. FDA's decision date was Oct 6, 2025, under product code ITI (Wheelchair, Powered).

Who makes the Wheelchair (N817)?

Zhejiang Topwe Tools Manufacturing Co.,Ltd, based in Yongkang, is the applicant of record for K251565.

How long did the K251565 review take?

FDA received the submission on May 22, 2025 and issued its decision on Oct 6, 2025, 137 days later.

← All decisions in October 2025