GRAVILAX TRACTION SYSTEM

K072064 · Therapeutic Clinical Technologies, Inc. · ITH · Apr 21, 2008 · Physical Medicine

Device Facts

• Record ID: K072064
• Device Name: GRAVILAX TRACTION SYSTEM
• Applicant: Therapeutic Clinical Technologies, Inc.
• Product Code: ITH · Physical Medicine
• Decision Date: Apr 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The GraviLax Traction System is intended for use in exerting therapeutic pulling forces on the patient's body. The device utilizes a cylindrical hot tub in which the patient is suspended vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles. This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.

Device Story

GraviLax Traction System provides spinal decompression via vertical suspension in a saline-filled cylindrical hot tub. Device utilizes buoyancy from high-salinity water (specific gravity ~1.2) to support patient weight while shoulder harness maintains vertical position. Decompressive force applied to sacral, lumbar, and thoracic spine via ankle weights. Used in clinical treatment facilities by qualified personnel. Benefits include spinal unloading through distraction and positioning. System is purely mechanical; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Powered traction equipment; cylindrical hot tub design; saline solution (specific gravity 1.2); shoulder harness; ankle weights. Mechanical operation; no software or electronic sensing components.

Indications for Use

Indicated for patients requiring therapeutic traction/decompression of the sacral, lumbar, and thoracic spine. Prescription use only; for use by qualified personnel in clinical treatment facilities.

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.

Predicate Devices

• HangUps InvertAlign (K991835)
• BAX-D Genesis System (K053503)
• Digit-Trac 930 Traction System (K052453)
• Extentrac Elite (K031996)
• DRS System (K981822)

Submission Summary (Full Text)

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APR 2 1 ZUUR

## 510(k) Summary

Daniel J. Manelli Submitted by: Manelli & Fisher, P.L.L.C. 5335 Wisconsin Ave., NW (Suite 440) Washington, DC 20015

Telephone: [phone]

On behalf of Therapeutic Clinical Technologies, Inc. 2655 South Rainbow Blvd. (Ste. 300) Las Vegas, Nevada 89146

510(k) Submission: GraviLax Traction Device Date: March 27, 2008

Description:

The device is a powered traction device pursuant to 21 CFR 890.5900 (FDA product code ITH) class 2. The device is substantially equivalent to various other traction devices which achieve their effect through the force of gravity and/or mechanical means, including the following:

HangUps InvertAlign; STL International Inc. K991835; BAX-D Genesis System; VAD-D Medical Technology Services, LLC. K053503; Digit-Trac 930 Traction System; Ever Prosperous Instrument, Inc. K052453; Extentrac Elite; Advanced Back Technologies, Inc. K031996; and DRS System; Professional Distribution Systems, Inc. K981822.

Indications for Use: The GraviLax Traction System is intended for use in exerting therapeutic pulling force on the patient's body. The device utilizes a cylindrical hot tub in which the patient is supported vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles. This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Therapeutic Clinical Technologies % Manelli & Fisher, P.L.L.C. Mr. Daniel J. Manelli 5335 Wisconsin Avenue, Suite 440 Washington, DC 20016

APR 2 1 2008

K072064 Re: Trade/Device Name: GraviLax Traction System Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II Product Code: ITH Dated: March 27, 2008 Received: March 28, 2008

Dear Mr. Manelli:

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). and Cosmetic Free (110) the elevice, subject to the general controls provisions of the Act. The I ou mayy more servisions 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 If your device to such additional controls. Existing major regulations affecting your device can may be our 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 Comply will an the Pet 270 cart 801); good manufacturing practice requirements as set OI It I art 607), moeing (21 CFR Part 820); and if applicable, the electronic forth in the quality by the (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Daniel J. Manelli

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit A

## Indications for Use

510(k) Number (if known): K072064

Device Name: GraviLax Traction System

Indications for Use:

The GraviLax Traction System is intended for use in exerting therapeutic pulling forces on the patient's body. The device utilizes a cylindrical hot tub in which the patient is suspended vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mxm

Division of General, Restorative, and Neurological Devices

**510(k) Number** K072064

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