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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 / June 2026 / K253812

510(k) cleared

Power Wheelchair (W5915B, W5915C, W5915D)

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Jun 18, 2026 · K253812

FDA cleared the Power Wheelchair (W5915B, W5915C, W5915D) from Zhejiang Innuovo Rehabilitation Devices Co.,Ltd on Jun 18, 2026 under K253812, 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 Nov 28, 2025. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd has 4 other decisions in the tracker over the last 12 months: K260094 (Mobility Scooter (W3465, W3902 (S50 Carbon))), K260176 (Mobility Scooter (W3483, W3483A)), K260056 (Power Wheelchair (N5515A, N5516, N5517A, N5519)), K253806 (Power Wheelchair (N5919 series)).

Questions & Answers

What did FDA clear under K253812?

K253812 is the FDA 510(k) for Power Wheelchair (W5915B, W5915C, W5915D), submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. FDA's decision date was Jun 18, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Power Wheelchair (W5915B, W5915C, W5915D)?

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, based in Dongyang, is the applicant of record for K253812.

How long did the K253812 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Jun 18, 2026, 202 days later.

← All decisions in June 2026

Sources