Cleared Traditional

K261149 - Electric Wheelchair (DY611A-2

K261149 is the FDA 510(k) clearance for Electric Wheelchair (DY611A-2 by Zhejiang Lumbre Electric Appliance Co., Ltd.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K261149 · Zhejiang Lumbre Electric Appliance Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
93d
Days
Class 2
Risk

K261149 is an FDA 510(k) clearance for the Electric Wheelchair (DY611A-2, DY612A-1). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Zhejiang Lumbre Electric Appliance Co., Ltd. (Lishui, CN). The FDA issued a Cleared decision on July 10, 2026 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Lumbre Electric Appliance Co., Ltd. devices

Submission Details

510(k) Number K261149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2026
Decision Date July 10, 2026
Days to Decision 93 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 173
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K261149.
Power Wheelchair (N5515A, N5516, N5517A, N5519)
K260056 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Jun 2026
Electric Wheelchair (DF506)
K260373 · Jiangsu Yveelt Medical Equipment Co., Ltd. · Jun 2026
Electric Wheelchair (Y207BL)
K253241 · Jiangsu Intco Medical Products Co., Ltd. · May 2026
Power Wheelchair (N5919 series)
K253806 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Apr 2026
Power Wheelchair (OS-R-M01S)
K253952 · Beijing OrionStar Technology Co., Ltd. · Apr 2026
Electric Wheelchair (AL-208S-063)
K253340 · Zhongshan A&J Medical Equipment Co., Ltd. · Apr 2026