510(k) K232692
K232692 is an FDA 510(k) premarket notification submitted by Intradin (Shanghai) Machinery Co., Ltd. for the device "Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)". The FDA issued a decision of Substantially Equivalent on September 5, 2024. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Intradin (Shanghai) Machinery Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2024
- Date Received
- September 5, 2023
- 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