510(k) K220207

Mobility Scooter, Model W3468 by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd — Product Code INI

K220207 is an FDA 510(k) premarket notification submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd for the device "Mobility Scooter, Model W3468". The FDA issued a decision of Substantially Equivalent on March 24, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2022
Date Received
January 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vehicle, Motorized 3-Wheeled
Device Class
Class II
Regulation Number
890.3800
Review Panel
PM
Submission Type