Cleared Traditional

K952675 - ORTHOFAB WHEELCHAIR

K952675 is an FDA 510(k) clearance for ORTHOFAB WHEELCHAIR, manufactured by Orthofab, Inc.. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K952675

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
Combination Product No
PCCP Authorized No
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.

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 401
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K952675.
OMEGATRAC BY TEFTEC
K955240 · Teftec Corp. · Jul 1996
HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND
K954131 · Hoveround Corp. · Jun 1996
JAZZY
K945936 · Pride Health Care, Inc. · May 1996
POWERCHAIR
K954135 · Wheelcare Scooters, Inc. · Apr 1996
MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
K950724 · Invacare Corp. · Aug 1995
GERONIMO
K935750 · Redman, Inc. · Feb 1995