Electric Wheelchair (0080)— 510(k) K262241
Substantially EquivalentXuzhou Heabens Medical Technology Co., Ltd.
FDA 510(k) clearance K262241 for Electric Wheelchair (0080), Substantially Equivalent on 2026-09-29. Applicant: Xuzhou Heabens Medical Technology Co., Ltd.. Device class: 2.
Summary
This is a powered wheelchair, model 0080, filed under ITI. The device name is generic ("Electric Wheelchair"), and the record doesn't add specs or features.
Class II, 21 CFR 890.3860, reviewed by the Physical Medicine panel as a Traditional 510(k).
Xuzhou Heabens Medical Technology Co., Ltd. filed from Xuzhou, China. The clock ran 90 days, from July 1 to September 29, 2026.
Clearance details
- Applicant
- Xuzhou Heabens 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
- Xuzhou, 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.