510(k) K171256
K171256 is an FDA 510(k) premarket notification submitted by Agile Distributors, LLC for the device "Quingo Flyte Mobility Scooter". The FDA issued a decision of Substantially Equivalent on Jun 8, 2017. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 2017
- Date Received
- Apr 28, 2017
- 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)