Cleared Special

K263257 - Electrically Powered Wheelchair (YC-01)

K263257 is an FDA 510(k) clearance for Electrically Powered Wheelchair (YC-01), manufactured by Yurob Rehabilitation Medical Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 26-day FDA review.

K263257 · Yurob Rehabilitation Medical Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
26d
Days
Class 2
Risk

K263257 is an FDA 510(k) clearance for the Electrically Powered Wheelchair (YC-01). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Yurob Rehabilitation Medical Co., Ltd. (Kunshan, CN). The FDA issued a Cleared decision on October 13, 2026 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K263257

510(k) Number K263257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2026
Decision Date October 13, 2026
Days to Decision 26 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 116d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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.
Andrew Wang

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 K263257.
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
Power Wheelchair (DC12)
K261079 · Anhui Jbh Medical Apparatus Co., Ltd. · Oct 2026
Power Wheelchair (D60)
K261200 · Anhui Jbh Medical Apparatus Co., Ltd. · Oct 2026
Electric Wheelchair (0080)
K262241 · Xuzhou Heabens Medical Technology Co., Ltd. · Sep 2026
K263257 · Electrically Powered Wheelchair (YC-01)
Download PDF FDA Summary Yurob Rehabilitation …