Electric wheelchair (D03)— 510(k) K261354
Substantially EquivalentFoshan Sowell Medical Technology Co., Ltd.
FDA 510(k) clearance K261354 for Electric wheelchair (D03), Substantially Equivalent on 2026-08-21. Applicant: Foshan Sowell Medical Technology Co., Ltd.. Device class: 2.
Summary
Foshan Sowell Medical Technology filed an Electric wheelchair, model D03, under product code ITI, powered wheelchairs. The device name is generic.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it was a Traditional 510(k).
Sowell filed from Foshan, China. Review took 119 calendar days (April 24 to August 21, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Foshan Sowell 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
- Foshan, 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.