Cleared Traditional

K263005 - Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)

K263005 is an FDA 510(k) clearance for Electric wheelchair (LW01301A02/LW01301..., manufactured by Anhui Longway Medical Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K263005 · Anhui Longway Medical Technology Co., Ltd. · Physical Medicine device
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Oct 2026
Decision
61d
Days
Class 2
Risk

K263005 is an FDA 510(k) clearance for the Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Anhui Longway Medical Technology Co., Ltd. (Mingguang, CN). The FDA issued a Cleared decision on October 28, 2026 after a review of 61 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K263005

510(k) Number K263005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2026
Decision Date October 28, 2026
Days to Decision 61 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 116d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

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 Consultant

Shanghai Sungo Management Consulting Co., Ltd.
Kiwi Xu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITI Wheelchair, Powered

All 596
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K263005.
Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S)
K261155 · Anhui Jbh Medical Apparatus Co., Ltd. · Oct 2026
Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M)
K261156 · Anhui Jbh Medical Apparatus Co., Ltd. · Oct 2026
Power Wheelchair (D39)
K261169 · Anhui Jbh Medical Apparatus Co., Ltd. · Oct 2026
Electric Wheelchair (CN501)
K262652 · Zhejiang Shimo Technology Co., Ltd. · Oct 2026
Electrically Powered Wheelchair (YC-01)
K263257 · Yurob Rehabilitation Medical Co., Ltd. · Oct 2026
Power Wheelchair (DC12)
K261079 · Anhui Jbh Medical Apparatus Co., Ltd. · Oct 2026
K263005 · Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)
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