EXONIX

K984199 · Fibra Sonics, Inc. · IMI · Feb 17, 1999 · Physical Medicine

Device Facts

• Record ID: K984199
• Device Name: EXONIX
• Applicant: Fibra Sonics, Inc.
• Product Code: IMI · Physical Medicine
• Decision Date: Feb 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fibra Sonics Exonix Ultrasound device is used to produce therapeutic deep heat for the following conditions: - Temporary relief of pain 1. - 2. Muscle Spasms - Joint contractures 3.

Device Story

Exonix is an ultrasound device generating therapeutic deep heat; used for temporary pain relief, muscle spasms, and joint contractures. Operated by healthcare professionals in clinical settings. Device delivers ultrasonic energy to tissues to induce thermal effects. Clinical benefit derived from heat-induced physiological response in targeted musculoskeletal conditions. Output is controlled by the clinician to manage treatment intensity.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device intent and general controls.

Technological Characteristics

Therapeutic ultrasound device; generates deep heat via ultrasonic energy. Class II device (Product Code IMI).

Indications for Use

Indicated for patients requiring therapeutic deep heat for temporary pain relief, muscle spasms, and joint contractures. Prescription use only.

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

FEB 1 7 1999

Mr. Robert Brohm Director of Quality Systems and Regulatory Affairs Fibra-Sonics, Inc. 5312 North Elston Avenue Chicago, Illinois 60630

K984199 Re: Trade Name: Exonix Requlatory Class: II Product Code: IMI Dated: November 20, 1998 November 24, 1998 Received:

Dear Mr. Brohm:

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 controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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. Robert Brohm

This letter will allow you to beqin 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 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 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,

Ma 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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## Indications For Use:

Device Name: Exonix

The Fibra Sonics Exonix Ultrasound device is used to produce therapeutic deep heat for the following conditions:

- Temporary relief of pain 1.
- 2. Muscle Spasms
- Joint contractures 3.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

pate

Prescription Use
X
(Per 21 CFR 801.109)

or

Over-The-Counter Use_