FDA 510(k) clearance · back to tracker

Electric Wheelchair (DY611A-2, DY612A-1)

Zhejiang Lumbre Electric Appliance Co., Ltd. cleared K261149 on 2026-07-10, decision: substantially equivalent

K-number

K261149

Sponsor

Zhejiang Lumbre Electric Appliance Co., Ltd.

Device

Electric Wheelchair (DY611A-2, DY612A-1)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-10

Product code

ITI

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3860

Official FDA record

Open K261149on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.