510(k) K222495

Mobility Scooter, Model: W3331F by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd — Product Code INI

K222495 is an FDA 510(k) premarket notification submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd for the device "Mobility Scooter, Model: W3331F". The FDA issued a decision of Substantially Equivalent on October 17, 2022. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Zhejiang Innuovo Rehabilitation Devices Co.,Ltd has at least 10 other 510(k) clearances on record.