FORTE, MODEL CPS ULTRASOUND

K982829 · Chattanooga Group, Inc. · IMI · Nov 6, 1998 · Physical Medicine

Device Facts

• Record ID: K982829
• Device Name: FORTE, MODEL CPS ULTRASOUND
• Applicant: Chattanooga Group, Inc.
• Product Code: IMI · Physical Medicine
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. The CPS Ultrasound, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

Device Story

The Forte CPS Ultrasound is a therapeutic device designed to deliver deep heat to soft tissues. It utilizes ultrasound applicators to generate therapeutic heating between 40°C and 45°C. The device is intended for use in clinical settings by healthcare professionals to treat conditions such as pain, muscle spasms, and joint contractures. By applying controlled thermal energy, the device aims to improve patient outcomes in physical therapy and rehabilitation contexts.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory review of device specifications and intended use.

Technological Characteristics

Therapeutic ultrasound device; provides deep heating (40-45°C); includes various applicators; operates in multiple modes; class II device.

Indications for Use

Indicated for patients requiring deep heat therapy for relief of pain, muscle spasms, and joint contractures associated with adhesive capsulitis, bursitis with slight calcification, myositis, and soft tissue injuries.

Regulatory Classification

Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 N. W

Mr. Joe Elrod Director of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee

Re : K982828 Forte CPS 400 Stim and Forte CPS 200 Stim Trade Names: Product Codes: GZJ, LIH, and IPF K982829 Forte CPS Ultrasound Trade Name: Product Code: IMI K982830 Forte CPS 400 Combo and Forte CPS 200 Combo Trade Names: Product Codes: GZJ, LIH, IPF, IMG, and IMI Regulatory Class: II Dated: August 10, 1998 August 11, 1998 Received:

Dear Mr. Elrod:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 aqainst misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ 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

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Page 2 - Mr. Joe Elrod

In addition, FDA may publish further announcements action. concerning your devices 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 requlations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling requlation (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 devices, 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Caroline M. Hitten, Ph.D.

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

Enclosures

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## CHATTANOOGA GROUP, INC.

## STATEMENT OF INDICATIONS FOR USE

For Ultrasound

Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. The CPS Ultrasound, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45°C in all of its operating modes.

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General Restorative Devices 510(k) Number

4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: [phone] Fax: [phone]

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