Cleared Special

K260145 - YJ-K1K2 Wheelchair (YJ-013F)

K260145 is an FDA 510(k) clearance for YJ-K1K2 Wheelchair (YJ-013F), manufactured by Zhenjiang Assure Medical Equipment Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Special 510(k) pathway after a 238-day FDA review.

K260145 · Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
238d
Days
Class 1
Risk

K260145 is an FDA 510(k) clearance for the YJ-K1K2 Wheelchair (YJ-013F). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Zhenjiang Assure Medical Equipment Co., Ltd. (Zhenjiang City, CN). The FDA issued a Cleared decision on September 15, 2026 after a review of 238 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zhenjiang Assure Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K260145

510(k) Number K260145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2026
Decision Date September 15, 2026
Days to Decision 238 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
122d slower than avg
Panel avg: 116d · This submission: 238d
Pathway characteristics
Modification to existing cleared device.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Shanghai Jiushun Enterprise Management Technology Service Co
Eric Shi

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 - IOR Wheelchair, Mechanical

All 312
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K260145.
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