Cleared Traditional

K161425 - APEX Manual Wheelchair

K161425 is the FDA 510(k) clearance for APEX Manual Wheelchair by Motion Composites. It is a Class 1 Physical Medicine device (product code IOR) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K161425 · Motion Composites · Physical Medicine device
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Dec 2016
Decision
196d
Days
Class 1
Risk

K161425 is an FDA 510(k) clearance for the APEX Manual Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Motion Composites (St-Roch-De-L'Achigan, CA). The FDA issued a Cleared decision on December 5, 2016 after a review of 196 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 Motion Composites devices

Submission Details

510(k) Number K161425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2016
Decision Date December 05, 2016
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 78
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K161425.
Kuschall Champion Manual Wheelchair
K162686 · Invacare Corporation · Dec 2016
Kuschall K-Series Attract Manual Wheelchair
K162692 · Invacare Corporation · Dec 2016
Kuschall Advance Manual Wheelchair
K162696 · Invacare Corporation · Dec 2016
MyOn HC Manual Wheelchair
K152536 · Invacare Corporation · Jan 2016
MEDLINE PEDIATRIC WHEELCHAIRS
K053574 · Medline Industries, Inc. · Jan 2006
EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR
K051302 · Medline Industries, Inc. · Aug 2005