510(k) K222507

Mobility Scooter (Models: W3431Q, W3431R) by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd — Product Code INI

K222507 is an FDA 510(k) premarket notification submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd for the device "Mobility Scooter (Models: W3431Q, W3431R)". The FDA issued a decision of Substantially Equivalent on February 28, 2023. 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
February 28, 2023
Date Received
August 18, 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