Electric wheelchair— 510(k) K253789
Substantially EquivalentZhejiang Yikang Medical Technology Co., Ltd.
FDA 510(k) clearance K253789 for Electric wheelchair, Substantially Equivalent on 2026-02-25. Applicant: Zhejiang Yikang Medical Technology Co., Ltd.. Device class: 2.
Summary
Zhejiang Yikang Medical Technology filed a device named only Electric wheelchair under product code ITI, powered wheelchair. The name is generic, and the record gives no models.
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).
Zhejiang Yikang Medical Technology filed from Lishui, China. The substantially equivalent decision came 89 calendar days after receipt (November 28, 2025 to February 25, 2026).
Clearance details
- Applicant
- Zhejiang Yikang Medical Technology 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
- Lishui, CN
Recent devices under product code ITI
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.