510(k) K062160

GO GO MINI, MODEL SC30 by Pride Mobility Products Corp. — Product Code INI

K062160 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "GO GO MINI, MODEL SC30". The FDA issued a decision of Substantially Equivalent on September 12, 2006. 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
September 12, 2006
Date Received
July 28, 2006
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