Cleared Traditional

K111278 - Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE

K111278 is an FDA 510(k) clearance for Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE, manufactured by Otto Bock Healthcare LP. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K111278 · Otto Bock Healthcare LP · Physical Medicine device
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Sep 2011
Decision
134d
Days
Class 2
Risk

K111278 is an FDA 510(k) clearance for the Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on September 16, 2011 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 - K111278

510(k) Number K111278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2011
Decision Date September 16, 2011
Days to Decision 134 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
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 221
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K111278.
HEARTWAY Electrically Powered Wheelchairs
K142731 · Heartway Medical Products Co., Ltd. · Feb 2015
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K141783 · Invacare Corporation · Jan 2015
HEARTWAY POWER WHEELCHAIR
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K100327 · Heartway Medical Products Co., Ltd. · Mar 2010
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K071005 · Heartway Medical Products Co., Ltd. · May 2007
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K071006 · Heartway Medical Products Co., Ltd. · May 2007