Cleared Traditional

DISCOVERY TMAX MANUAL WHEELCHAIR (K113164) - FDA 510(k) Clearance

Class I Physical Medicine device.

K113164 · Otto Bock Healthcare LP · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
502d
Days
Class 1
Risk

K113164 is an FDA 510(k) clearance for the DISCOVERY TMAX MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on March 11, 2013 after a review of 502 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Otto Bock Healthcare LP devices

Submission Details

510(k) Number K113164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2011
Decision Date March 11, 2013
Days to Decision 502 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
387d slower than avg
Panel avg: 115d · This submission: 502d
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 77
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K113164.
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
MEDLINE EXCEL RECLINCER WHEELCHAIR
K013761 · Medline Industries, Inc. · Dec 2001