Cleared Traditional

K952675 - ORTHOFAB WHEELCHAIR

K952675 is the FDA 510(k) clearance for ORTHOFAB WHEELCHAIR by Orthofab, Inc.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K952675 · Orthofab, Inc. · Physical Medicine device
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May 1996
Decision
330d
Days
Class 2
Risk

K952675 is an FDA 510(k) clearance for the ORTHOFAB WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Orthofab, Inc. (Quebec, Quebec, CA). The FDA issued a Cleared decision on May 7, 1996 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Orthofab, Inc. devices

Submission Details

510(k) Number K952675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date May 07, 1996
Days to Decision 330 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 115d · This submission: 330d
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 173
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K952675.
TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
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ACTION STORM RANGER II, ACTION STORM POWER 9000
K982064 · Invacare Corp. · Oct 1998
MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
K950724 · Invacare Corp. · Aug 1995
MODEL MCC - MKIV MICRO COMPUTER CONTROLS
K940972 · Invacare Corp. · Jun 1994
ACTION STORM POWER WHEELCHAIR
K940051 · Invacare Corp. · Mar 1994