510(k) K172440
K172440 is an FDA 510(k) premarket notification submitted by Dongguan Prestige Sporting Goods., Ltd. for the device "Solax Electric Scooter, Models: S302121, S302131, S302141, S302151". The FDA issued a decision of Substantially Equivalent on Jul 13, 2018. 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 13, 2018
- Date Received
- Aug 11, 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)