Cleared Traditional

K013307 - OMEGATRAC, MODEL Z105

K013307 is an FDA 510(k) clearance for OMEGATRAC, manufactured by Teftec Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K013307 · Teftec Corp. · Physical Medicine device
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Feb 2002
Decision
127d
Days
Class 2
Risk

K013307 is an FDA 510(k) clearance for the OMEGATRAC, MODEL Z105. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Teftec Corp. (San Antonio, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 127 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 Teftec Corp. devices

FDA 510(k) Submission Details - K013307

510(k) Number K013307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date February 08, 2002
Days to Decision 127 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
12d slower than avg
Panel avg: 115d · This submission: 127d
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 295
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K013307.
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K012927 · Invacare Corp. · Sep 2001