QUEST INTERSEGMENTAL ROLLER TRACTION TABLE

K993461 · Icon Intl., LLC · JFB · Jan 3, 2000 · Physical Medicine

Device Facts

• Record ID: K993461
• Device Name: QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
• Applicant: Icon Intl., LLC
• Product Code: JFB · Physical Medicine
• Decision Date: Jan 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Quest Intersegmental Roller 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

Quest Intersegmental Roller Traction Table is a mechanical device used in clinical settings to provide massage therapy. It utilizes electric motors to drive a roller carriage that moves longitudinally along the patient's spine, spanning from the cervical to the lumbar region. The device incorporates vibration and optional heat to facilitate muscle tension release. It is operated by a clinician or technician to deliver soothing massage. The device provides physical mechanical stimulation to the patient's back, intended to benefit the patient through muscle relaxation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical intersegmental roller traction table; powered by electric motors; features roller carriage mechanism, vibration, and optional heat; intended for cervical to lumbar application.

Indications for Use

Indicated for patients requiring muscle tension release and massage therapy from the cervical to the lumbar region.

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.

Submission Summary (Full Text)

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Public Health Service

JAN - 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gerald S. Auslander Managing Member Icon International LLC 300 Ozark Trail Drive, #207 C Ellisville, Missouri 63011

Re: K993461

Trade Name: Ouest Intersegmental Roller Traction Table Regulatory Class: II Product Code: JFB Dated: October 5, 1999 Received: October 13, 1999

Dear Mr. Auslander:

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 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). 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 requirements, as set forth in the Quality System Regulation (OS) 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.

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Page 2 - Mr. Gerald S. Auslander

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Picard J. Lager

- for 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): K993461

Device Name: Quest Intersegmental Roller Traction Table

Indications For Use:

The Quest Intersegmental Roller 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pierre G. S. Lygum

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)