LORDEX POWER TRACTION EQUIPMENT

K031227 · Ever Prosperous Instrument, Inc. · ITH · Jul 17, 2003 · Physical Medicine

Device Facts

• Record ID: K031227
• Device Name: LORDEX POWER TRACTION EQUIPMENT
• Applicant: Ever Prosperous Instrument, Inc.
• Product Code: ITH · Physical Medicine
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lordex Power Traction Unit provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the Lordex Traction Unit, and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is unloading due to distraction and positioning.

Device Story

Lordex Power Traction Unit provides physician-prescribed treatment for low back pain; delivers static, intermittent, and cycling distraction forces to spine; achieves decompression of intervertebral discs via unloading through distraction and positioning; used in clinical settings; intended to relieve pain associated with herniated/protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Power traction equipment; provides static, intermittent, and cycling distraction forces for spinal decompression.

Indications for Use

Indicated for patients suffering from low back pain, including herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Regulatory Classification

Identification

Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

Dr. John Boren President Lordex, Inc. 15915 Katy Freeway, Suite 645 Houston, Texas 77094

Re: K031227

Trade Name: Lordex Power Traction Unit Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: March 27, 2003 Received: May 6, 2003

Dear Dr. Boren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.'

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 - Dr. John Boren

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Milliman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

March 27, 2003

Lordex Inc.

Device Name: Lordex Power Traction Unit 510k Pre market notification number KO31227

Indications For Use:

## Intended Use:

The Lordex Power Traction Unit provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the Lordex Traction Unit, and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is unloading due to distraction and positioning.

Concurrence of CDRH, Office of Device Evaluation

Division sign off

510k Number KO31227

Prescription Use し (Per 21 CFR 801.109)

OR

Over-The-Counter Use

to Monk N Millikan

(Division Sign-Off) Di ision of General, Restorative and Neurological Devices

510(k) Number K031227