Cleared Traditional

K130517 - EZ TRANSPORT CHAIR

K130517 is an FDA 510(k) clearance for EZ TRANSPORT CHAIR, manufactured by Harris Medical, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K130517 · Harris Medical, LLC · Physical Medicine device
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Feb 2014
Decision
363d
Days
Class 1
Risk

K130517 is an FDA 510(k) clearance for the EZ TRANSPORT CHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Harris Medical, LLC (Amherst, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Harris Medical, LLC devices

FDA 510(k) Submission Details - K130517

510(k) Number K130517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2013
Decision Date February 25, 2014
Days to Decision 363 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
248d slower than avg
Panel avg: 115d · This submission: 363d
Pathway characteristics
Predicate-based equivalence.

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 Peers - IOR Wheelchair, Mechanical

All 105
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K130517.
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