CTBOX CERVICAL/LUMBAR TRACTION

K063353 · Circular Traction Supply, Inc. · ITH · Mar 14, 2007 · Physical Medicine

Device Facts

• Record ID: K063353
• Device Name: CTBOX CERVICAL/LUMBAR TRACTION
• Applicant: Circular Traction Supply, Inc.
• Product Code: ITH · Physical Medicine
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The "CT Box™" cervical/lumbar traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic/lumbogenic pain symptoms of mechanical origin related to reduced cervical or lumbar lordosis/extension and altered posture. It temporarily positions the cervical or lumbar spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

Device Story

CTBox is a non-powered, mechanical traction system designed to treat cervicogenic and lumbogenic pain. Device functions by positioning the cervical or lumbar spine into an extension posture of varying degrees to address mechanical pain symptoms related to reduced lordosis or altered posture. Operated by clinicians in a professional setting; intended as a conservative treatment alternative. Device is non-sterile and requires prescription. No electronic components, software, or automated algorithms involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical traction system for cervical/lumbar spinal positioning. Non-powered, non-sterile, prescription-only device. No software, sensors, or electronic components.

Indications for Use

Indicated for patients with cervicogenic or lumbogenic pain of mechanical origin associated with reduced cervical or lumbar lordosis/extension and altered posture.

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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2007

Circular Traction Supply, Inc. % Donald W. Meyer, D.C. President 7602 Talbert Avenue, Unit #9 Huntington Beach, California 92648

K063353 Re:

> Trade/Device Name: CTBox Cervical/Lumbar Traction System Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH, ILZ, IRS Dated: February 14, 2007 Received: February 20, 2007

Dear Dr. Meyer:

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

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## Page 2 - Donald W. Meyer, D.C.

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. 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/industry/support/index.html.

Sincerely yours,

Barbara Burchill

for

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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## Section 12 - Indications for Use Statement

## Applicant: Donald W. Mever, DC 510(k) Number (if known): K063353 Device Name: "CTBox"M" Cervical/Lumbar Traction Indications For Use:

The "CT Box™" cervical/lumbar traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic/lumbogenic pain symptoms of mechanical origin related to reduced cervical or lumbar lordosis/extension and altered posture. It temporarily positions the cervical or lumbar spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ondrew Buchm

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K063353

Section 12.1