Electric Wheelchair (DY611A-2, DY612A-1)— 510(k) K261149
Substantially EquivalentZhejiang Lumbre Electric Appliance Co., Ltd.
FDA 510(k) clearance K261149 for Electric Wheelchair (DY611A-2, DY612A-1), Substantially Equivalent on 2026-07-10. Applicant: Zhejiang Lumbre Electric Appliance Co., Ltd.. Device class: 2.
Summary
Zhejiang Lumbre Electric Appliance's Electric Wheelchair comes in two models, DY611A-2 and DY612A-1, filed under ITI, powered wheelchairs. The record doesn't say how they differ.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Zhejiang Lumbre filed from Lishui, China. Review took 93 calendar days (April 8 to July 10, 2026).
Clearance details
- Applicant
- Zhejiang Lumbre Electric Appliance 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.