Virgo Mobility Scooter (Virgo-D,Virgo-F)— 510(k) K253257
Substantially EquivalentJiangsu Intco Medical Products Co., Ltd.
FDA 510(k) clearance K253257 for Virgo Mobility Scooter (Virgo-D,Virgo-F), Substantially Equivalent on 2026-06-08. Applicant: Jiangsu Intco Medical Products Co., Ltd.. Device class: 2.
Summary
Jiangsu Intco Medical Products' Virgo Mobility Scooter comes in two models, Virgo-D and Virgo-F. It's filed under INI, motorized three-wheeled vehicles, and the record doesn't say how the models differ.
Class II, 21 CFR 890.3800. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Intco filed from Zhenjiang, China. Review took 252 calendar days (September 29, 2025 to June 8, 2026).
Clearance details
- Applicant
- Jiangsu Intco Medical Products Co., Ltd.
- Product code
- Product code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhenjiang, CN
Recent devices under product code INI
view allMore clearances from Jiangsu Intco Medical Products Co., Ltd.
view allAdverse events under product code INI
product code INI- Injury
- 171
- Other
- 1
- Total
- 172
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.