510(k) K240990

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

K240990 is an FDA 510(k) premarket notification submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd for the device "Mobility Scooter". The FDA issued a decision of Substantially Equivalent on September 10, 2024. 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
September 10, 2024
Date Received
April 11, 2024
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