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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 / August 2026 / K260176

510(k) cleared

Mobility Scooter (W3483, W3483A)

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Aug 10, 2026 · K260176

FDA cleared the Mobility Scooter (W3483, W3483A) from Zhejiang Innuovo Rehabilitation Devices Co.,Ltd on Aug 10, 2026 under K260176, a traditional 510(k). The device falls under product code INI, Vehicle, Motorized 3-Wheeled, regulated at 21 CFR 890.3800 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jan 21, 2026. The decision came 201 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))), K253812 (Power Wheelchair (W5915B, W5915C, W5915D)), K260056 (Power Wheelchair (N5515A, N5516, N5517A, N5519)), K253806 (Power Wheelchair (N5919 series)).

Questions & Answers

What did FDA clear under K260176?

K260176 is the FDA 510(k) for Mobility Scooter (W3483, W3483A), submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. FDA's decision date was Aug 10, 2026, under product code INI (Vehicle, Motorized 3-Wheeled).

Who makes the Mobility Scooter (W3483, W3483A)?

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, based in Dongyang, is the applicant of record for K260176.

How long did the K260176 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Aug 10, 2026, 201 days later.

← All decisions in August 2026

Sources