510(k) K191356
K191356 is an FDA 510(k) premarket notification submitted by Puc Perfect Union Co., Ltd. for the device "i3 Foldable Mobility Scooter". The FDA issued a decision of Substantially Equivalent on Jan 11, 2022. 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
- Jan 11, 2022
- Date Received
- May 21, 2019
- 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)