510(k) K253257
K253257 is an FDA 510(k) premarket notification submitted by Jiangsu Intco Medical Products Co., Ltd. for the device "Virgo Mobility Scooter (Virgo-D,Virgo-F)". The FDA issued a decision of Substantially Equivalent on June 8, 2026. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Jiangsu Intco Medical Products Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 2026
- Date Received
- September 29, 2025
- 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