Cleared Traditional

DISCOVERY TMAX MANUAL WHEELCHAIR

K113164 · Otto Bock Healthcare LP · Physical Medicine

Mar 2013

Decision

502d

Days

Class 1

Risk

About This 510(k) Submission

K113164 is an FDA 510(k) clearance for the DISCOVERY TMAX MANUAL WHEELCHAIR, 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 March 11, 2013, 502 days after receiving the submission on October 26, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K113164 FDA.gov
FDA Decision	Cleared 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

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.