510(k) K091113
K091113 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V". The FDA issued a decision of Substantially Equivalent on May 11, 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
- May 11, 2009
- Date Received
- April 17, 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