510(k) K170634
K170634 is an FDA 510(k) premarket notification submitted by Advanced Vehicle Concepts , Ltd. for the device "Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350". The FDA issued a decision of Substantially Equivalent on Nov 29, 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
- Nov 29, 2017
- Date Received
- Mar 2, 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)