Cleared Traditional

CENTRO FAMILY OF MANUAL WHEELCHAIRS

K111045 · Otto Bock Healthcare LP · Physical Medicine

Jul 2011

Decision

91d

Days

Class 1

Risk

About This 510(k) Submission

K111045 is an FDA 510(k) clearance for the CENTRO FAMILY OF MANUAL WHEELCHAIRS, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on July 15, 2011, 91 days after receiving the submission on April 15, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K111045 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — 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.