Cleared Traditional

K131336 - TX WHEELCHAIR CHASSIS

K131336 is an FDA 510(k) clearance for TX WHEELCHAIR CHASSIS, manufactured by Jcm Seating Solutions, Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K131336 · Jcm Seating Solutions, Ltd. · Physical Medicine device
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Oct 2013
Decision
172d
Days
Class 1
Risk

K131336 is an FDA 510(k) clearance for the TX WHEELCHAIR CHASSIS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Jcm Seating Solutions, Ltd. (Austin, US). The FDA issued a Cleared decision on October 28, 2013 after a review of 172 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. 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. Standard predicate reliance. 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 Jcm Seating Solutions, Ltd. devices

FDA 510(k) Submission Details - K131336

510(k) Number K131336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2013
Decision Date October 28, 2013
Days to Decision 172 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 115d · This submission: 172d
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 Peers - IOR Wheelchair, Mechanical

All 105
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