Cleared Special

K993160 - OMEGA TRAC, MODEL Z100

K993160 is an FDA 510(k) clearance for OMEGA TRAC, manufactured by Teftec Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 58-day FDA review.

K993160 · Teftec Corp. · Physical Medicine device
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Nov 1999
Decision
58d
Days
Class 2
Risk

K993160 is an FDA 510(k) clearance for the OMEGA TRAC, MODEL Z100. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Teftec Corp. (Spring Branch, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K993160

510(k) Number K993160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1999
Decision Date November 18, 1999
Days to Decision 58 days
Submission Type Special
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
58d faster than avg
Panel avg: 116d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 549
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K993160.
TRX-CG POWER TILT AND RECLINE SYSTEM
K994241 · Motion Concepts · Jan 2000
RTD ARM ASSISTIVE ROBOTIC DEVICE
K993443 · Rehabilitation Technologies Division · Dec 1999
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K993413 · Invacare Corp. · Dec 1999
MODIFICATION TO MP-3 POWER BASE CHAIR
K993032 · Merits Health Products., Inc. · Nov 1999
THE BRUNO POWERBASE, MODEL PSB-2200
K991954 · Bruno Independent Living Aids, Inc. · Nov 1999
AMIGO MODEL 680000 (AMIGO EXCITE F 350)
K992619 · Amigo Mobility Intl., Inc. · Oct 1999
K993160 · OMEGA TRAC, MODEL Z100
Download PDF Teftec Corp.