HES ULTRASONIC THERAPY APPLIANCE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes stacked on top of each other, possibly representing human figures or abstract forms. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 4 2004 Hwang Sun Enterprise Company, Ltd. C/o Richard C. Lanzillotto NATS Corporation 30 Northport Road Sound Beach, New York 11789 Re: K040798 K040776 Trade/Device Name: HES® Ultrasonic Therapy Appliance Model 3003 and Model 3006 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: May 13, 2004 Received: May 17, 2004 Dear Mr. Lanzillotto: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce print to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de rices mat nave been receasined require approval of a premarket approval application (PMA). and Costietle Act (110) that as noves participant to the general controls provisions of the Act. The I ou may, incretere, mains of the Act include requirements for annual registration, listing of general voltable pro receive, 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 is elassinod (600 a00 rols. Existing major regulations affecting your device can may be subject to back as a 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 r least of actived that i Drimination that your device complies with other requirements of the Act that I DA has made a avoid regulations administered by other Federal agencies. You must of any I catal statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It 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. {1}------------------------------------------------ Page 2 - Richard C. Lanzillotto This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your he FDA finding of substantial equivalence of your device to a legally premaince hodicate 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 If you desire specific at no 101 - 501) 594-4659. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark A. Milken Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ു. Issued: 03-17-04 Revised: 07-20-04 HES® Ultrasonic Therapy Appliance 510K Notification K040798 ## INDICATIONS FOR USE | 510(k) Number (if known): | K040798 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | HES® Ultrasonic Therapy Appliance | | Indications for Use: | The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. | Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below this line-continue on another Page if needed) ューーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Mckinnon Page 1 of 1 (Division Sign-on) Restorative, Division of Or of Occal Devices K040798 **510(k) Number-**