Cleared Traditional

A-200 POWERED WHEELCHAIR (K052706) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052706 · Otto Bock Healthcare LP · Physical Medicine device
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Dec 2005
Decision
90d
Days
Class 2
Risk

K052706 is an FDA 510(k) clearance for the A-200 POWERED WHEELCHAIR. 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 December 27, 2005 after a review of 90 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

Submission Details

510(k) Number K052706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date December 27, 2005
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 171
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K052706.
HEARTWAY Electrically Powered Wheelchair P27
K142783 · Heartway Medical Products Co., Ltd. · Jun 2015
HEARTWAY Electrically Powered Wheelchairs
K142731 · Heartway Medical Products Co., Ltd. · Feb 2015
TDX SP2 POWER WHEECHAIR
K141783 · Invacare Corporation · Jan 2015
INVACARE 3G TARSYS
K033819 · Invacare Corp. · Jun 2004
STORM TDX POWER WHEELCHAIR
K023589 · Invacare Corp. · Nov 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002