Mobility Scooter (X-12, X-14, X-17)— 510(k) K260237
Substantially EquivalentWuyi Aichi Industry and Trade Co., Ltd.
FDA 510(k) clearance K260237 for Mobility Scooter (X-12, X-14, X-17), Substantially Equivalent on 2026-04-22. Applicant: Wuyi Aichi Industry and Trade Co., Ltd.. Device class: 2.
Summary
Wuyi Aichi Industry and Trade's Mobility Scooter comes in three models, X-12, X-14, and X-17, filed under product code INI (Vehicle, Motorized 3-Wheeled). The record doesn't say how they differ.
Class II, 21 CFR 890.3800. It came in as a Traditional 510(k), and Physical Medicine is both the classification panel and the review panel.
Wuyi Aichi Industry and Trade filed from Jinhua, China. Review took 86 calendar days (January 26 to April 22, 2026).
Clearance details
- Applicant
- Wuyi Aichi Industry and Trade 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
- Jinhua, CN
Recent devices under product code INI
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.