510(k) K182471
K182471 is an FDA 510(k) premarket notification submitted by Tianjin Kepler Vehicle Industry Co. , Ltd. for the device "Scooter". The FDA issued a decision of Substantially Equivalent on Jul 10, 2019. 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
- Jul 10, 2019
- Date Received
- Sep 10, 2018
- 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)