CTD MARK I TRACTION DEVICE

K991931 · Therasys, Inc. · ITH · Aug 12, 1999 · Physical Medicine

Device Facts

• Record ID: K991931
• Device Name: CTD MARK I TRACTION DEVICE
• Applicant: Therasys, Inc.
• Product Code: ITH · Physical Medicine
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CTD Mark I is a mobile, cervical, pneumatic pulling-traction device expressly used to perform traction and mobilization of the cervical muscles and vertebrae. It provides intermittent or continuous traction modes. The CTD Mark I when used as a cervical traction device is for clinical use only by prescription of a licensed physician.

Device Story

CTD Mark I is a mobile, pneumatic cervical traction device. It applies intermittent or continuous pulling force to cervical muscles and vertebrae to facilitate mobilization. Device is intended for clinical use by healthcare professionals under physician prescription. Output is mechanical traction force; assists in physical therapy or rehabilitation settings. Benefits include controlled, adjustable cervical decompression or mobilization to address musculoskeletal conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic traction system; mobile form factor; provides intermittent or continuous traction modes. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring cervical traction and mobilization of cervical muscles and vertebrae. For clinical use only by prescription of a licensed physician.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Earnie S. Philpot President Therasys, Incorporated 2295 North Moraine Drive Moraine, Ohio 45439

Re: K991931 Trade Name: CTD Mark I Traction Device Regulatory Class: II Product Code: ITH Dated: June 3, 1999 Received: June 8, 1999

Dear Mr. Philpot:

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 control provisions of the Act. The general control 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 (OS) 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. Earnie S. Philpot

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

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

Enclosure

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IC99/93//A

Food and Drug Administration

June 22, 1999

DUPLICATE

510K Number: K991931

Device Name: CTD MARK I TRACTION DEVICE

INDICATIONS FOR USE:

The CTD Mark I is a mobile, cervical, pneumatic pulling-traction device expressly used to perform traction and mobilization of the cervical muscles and vertebrae. It provides intermittent or continuous traction modes. The CTD Mark I when used as a cervical traction device is for clinical use only by prescription of a licensed physician.

P. O'Dell

(Division Sign Off) Division of General Restorative Devices 510(k) Number

2007

Prescription Use
(Per 21 CFR 801.109)