Cleared Traditional

K111045 - CENTRO FAMILY OF MANUAL WHEELCHAIRS

K111045 is an FDA 510(k) clearance for CENTRO FAMILY OF MANUAL WHEELCHAIRS, manufactured by Otto Bock Healthcare LP. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K111045 · Otto Bock Healthcare LP · Physical Medicine device
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Jul 2011
Decision
91d
Days
Class 1
Risk

K111045 is an FDA 510(k) clearance for the CENTRO FAMILY OF MANUAL WHEELCHAIRS. 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 July 15, 2011 after a review of 91 days - within the typical 510(k) review window.

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 Otto Bock Healthcare LP devices

FDA 510(k) Submission Details - K111045

510(k) Number K111045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2011
Decision Date July 15, 2011
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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 93
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K111045.
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