510(k) K090524

GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV by Pride Mobility Products Corp. — Product Code INI

K090524 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV". The FDA issued a decision of Substantially Equivalent on March 19, 2009. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Pride Mobility Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2009
Date Received
February 26, 2009
Clearance Type
Special
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