OMEGA TRAC, MODEL Z100 by TEFTEC CORP.

ΩmegaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the ΩmegaTrac® with no modifications.

This usage would be indicated but not limited to the following types of injury's:

Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Brown Sequard's Syndrome Severe Arthritics (RA) (OA) Multiple Scierosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Scierosis (ALS) Anoxic Encephalopathy Anoxia

Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's

This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an ΩmegaTrac® powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, I cannot answer the question regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a powered wheelchair, the OmegaTrac®. It confirms the device is substantially equivalent to a predicate device but does not contain information about specific acceptance criteria or details of a study proving those criteria were met, such as sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory approval letter, not a clinical study report.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Mr. Thomas E. Finch III President TEFTEC Corporation 6929 Old Spring Branch Road Spring Branch, Texas 78070

K993160 Re: OmegaTrac® Powered Wheelchair Trade Name: Regulatory Class: II Product Code: ITI Dated: September 10, 1999 October 26, 1999 Received:

Dear Mr. Finch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Thomas E. Finch III

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN): K9931 60

DEVICE NAME:

QmegaTrac® Powered Wheelchair

INDICATIONS FOR USE:

Indications for use for the ΩmegaTrac® Powered Wheelchair base:

QmegaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the 02megaTrac® with no modifications.

This usage would be indicated but not limited to the following types of injury's:

Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's

This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an S2megaTrac® powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.

If you have any further questions, please feel free to contact us directly.

(Please Do Not Write Below This Line-Continue On Another Page If Needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Revised 11/13/1998

Over-The-Counter-Use	✓
(Optional Format 1 /2 - 96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K993160

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. 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.(b)
Classification. Class II (performance standards).