510(k) K063389
K063389 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54". The FDA issued a decision of Substantially Equivalent on November 17, 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
- November 17, 2006
- Date Received
- November 2, 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