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.
Clearance details
- Applicant
- Wuyi Aichi Industry and Trade Co., Ltd.
- Product code
- 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.