QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H

K002390 · Lsi Intl., Inc. · JFB · Nov 2, 2000 · Physical Medicine

Device Facts

• Record ID: K002390
• Device Name: QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
• Applicant: Lsi Intl., Inc.
• Product Code: JFB · Physical Medicine
• Decision Date: Nov 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quantum Intersegmental Roller Traction Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.

Device Story

The Quantum Intersegmental Roller Traction Table is a physical therapy device used to release muscle tension and provide massage. The device consists of three rollers, each six inches wide and six inches in diameter, mounted on a carriage. The rollers rotate clockwise or counter-clockwise while tracking longitudinally along the patient's back. The patient lies in a supine position on the table. The operator adjusts the roller height to control the degree of pressure applied to the back muscles. The system utilizes electric motors to drive the roller carriage movement from the cervical to the lumbar region, supplemented by vibration and optional heat. The device is intended for use in a clinical setting to provide therapeutic massage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device features three 6-inch wide, 6-inch diameter rollers. It is powered by electric motors and includes vibration and optional heat functions. The system is designed for supine patient positioning with adjustable roller height for pressure control.

Indications for Use

Indicated for patients requiring release of muscle tension and massage therapy. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.

Predicate Devices

• Quest Intersegmental Roller Traction Table (K993461)

Submission Summary (Full Text)

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NOV = 2 2000

Image /page/0/Picture/1 description: The image shows a logo for LSI International, with the words "Health Care" to the left and "Specialty" to the right. Above the word "Specialty" is the number 002390. The logo is placed between two horizontal lines.

#### 510(k) SUMMARY

## LSI INTERNATIONAL, INC.

July 31, 2000

#### Submitter Information:

LSI International, Inc. 8849 Bond Overland Park, KS 66214

Submitter's Name: Phone:

James C. Lane 913/894-4493

#### Device Names:

| Proprietary Name: | Quantum Intersegmental Roller Traction Table |
|----------------------|----------------------------------------------|
| Common Name: | Intersegmental Roller Traction Table |
| Classification Name: | Multi-functional Physical Therapy Table |

#### Predicate Device Equivalence:

Substantial equivalence is claimed to the Quest Intersegmental Roller Traction Table, cleared for commercial distribution per K993461,

Indications: The Quantum Intersegmental Roller Traction Table is designed to release muscle tension and deliver a soothing massage.

Description: The Quantum Intersegmental Roller Traction Table features three six inch wide, six inch diameter rollers which rotate in a clockwise or counter-clockwise direction while tracking up and down the back. The roller height can be adjusted to place varying degrees of pressure on the muscles of the back while the patient is lying in the supine position.

Page 16 of 16

LSI INTERNATIONAL 8849 BOND OVERI AND PARK, KS 66214 [phone]

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV = 2 2000

Mr. James Lane CEO LSI International, Inc. 8849 Bond Overland Park, Kansas 66214

Re: K002390

Trade Name: Quantum Intersegmental Roller Traction Table Regulatory Class: Class II Product Code: JFB Dated: October 10, 2000 Received: October 11, 2000

Dear Mr. Lane:

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A 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 action. In addition, FDA may publish further announcements 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.

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.

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## Page 2 - Mr. James Lane

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific active for your do the secontact the Office of Compliance at additionally 607.10 for mi viro allestions on the promotion and advertising of your device, [phone]. prease connact the Office or Semperation of the stime (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respeat its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Styt Rhodes

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

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510(k) Number (if known) K002390

Device Name: Quantum Intersegmental Roller Traction Table

### Indications for Use:

The Quantum Intersegmental Roller Traction Table uses a roller mechanism and electric motors coupled with vibration and optional heat to release muscle tension and deliver soothing massage by the movement of the roller carriage back and forth from the cervical area to the lumbar area of the patient.

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Concurrence of CDRH, Office of Devi ce Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
|-----------------------------------------|--------------------------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K002390 |

| Prescription Use | X | OR | Over-the-Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

(Per 21 CFR 801.109)

Optional Format 1-2-96