Electric Wheelchair (Y207BL)— 510(k) K253241
Substantially EquivalentJiangsu Intco Medical Products Co., Ltd.
FDA 510(k) clearance K253241 for Electric Wheelchair (Y207BL), Substantially Equivalent on 2026-05-13. Applicant: Jiangsu Intco Medical Products Co., Ltd.. Device class: 2.
Summary
Jiangsu Intco Medical Products' Electric Wheelchair (Y207BL) is filed under ITI, powered wheelchairs. Apart from the model number, the name is generic.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Intco filed from Zhenjiang, China. Review took 226 calendar days (September 29, 2025 to May 13, 2026).
Clearance details
- Applicant
- Jiangsu Intco Medical Products Co., Ltd.
- Product code
- Product code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhenjiang, CN
Recent devices under product code ITI
view allMore clearances from Jiangsu Intco Medical Products Co., Ltd.
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
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.