Cleared Traditional

K120526 - YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR

K120526 is an FDA 510(k) clearance for YUYUE K2 WHEELCHAIR, manufactured by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K120526 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Physical Medicine device
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Mar 2012
Decision
15d
Days
Class 1
Risk

K120526 is an FDA 510(k) clearance for the YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Northbrook, US). The FDA issued a Cleared decision on March 8, 2012 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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.

View all Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. devices

FDA 510(k) Submission Details - K120526

510(k) Number K120526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2012
Decision Date March 08, 2012
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Underwriters Laboratories, Inc.

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 K120526.
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
K111636 · Gunnell, Inc. · Apr 2012
JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
K112948 · Jiangsu Healthy Way Medical Equipment Co;Ltd · Mar 2012
JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
K112950 · Jiangsu Healthy Medical Equipment Co;Ltd · Mar 2012
KIDS ROCK 3 CHAIR
K111739 · Pride Mobility Products Corp. · Aug 2011
CENTRO FAMILY OF MANUAL WHEELCHAIRS
K111045 · Otto Bock Healthcare LP · Jul 2011
INNOVA WHEELCHAIR
K110788 · Columbia Medical Manufacturing, LLC · May 2011

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.