510(k) K133187
K133187 is an FDA 510(k) premarket notification submitted by Freerider Corp for the device "FREERIDER FR1, models FR1-13, FR1-15, FR1-17". The FDA issued a decision of Substantially Equivalent on Jan 8, 2015. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Freerider Corp has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 2015
- Date Received
- Oct 17, 2013
- 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
- 510(k)