SONICATOR 740, MODEL ME 740

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines beneath them. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 1 6 2006 Mettler Electronics Corp. % Mr. Robert E. Fleming Director, QA/RA 1333 South Claudina Street Anaheim, California 92805 Re: K053546 Trade/Device Name: Sonicator 740, Model ME 740 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI Dated: April 24, 2006 Received: April 25, 2006 Dear Mr. Fleming: This letter corrects our substantially equivalent letter of May 4, 2006. 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 (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 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 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. {1}------------------------------------------------ Page 2 - Mr. Robert E. Fleming This letter will allow you to continue marketing your device as described in your Section 510(k) This letter will anow you to continue mag of substantial equivalence of your device to a legally premated predicated on "ce 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 it you don't specific as nollance at (240) 276-0120. 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Barbara buchuk Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K053546 Sonicator® 740, Model ME 740 Device Name: Indications for Use: Ultrasound delivered to the body using an efficient couplant provides deep heating effects to body tissues. Ultrasound delivered at a frequency of 1 MHz penetrates to a depth of approximately 5 centimeters while ultrasound at a frequency of 3.3 or 3.2 MHz penetrates tissue to a depth of approximately 1-2 cm. When therapeutic ultrasound is delivered to the body at intensities capable of generating a deep tissue temperature increase, some or all of the following effects may occur: - 1. Pain relief - 2. Reduction of muscle spasm - 3. Localized increase in blood flow - 4. Increase range of motion of contracted joints using heat and stretch techniques. Prescription Use (Per CFR 801 Subpart D) AND/OR Over the Counter Use (Per 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) Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices **510(k) Number** K053546 Image /page/2/Picture/19 description: The image shows a black and white abstract pattern. The pattern is composed of many small black dots and shapes clustered together. The density of the black elements varies across the image, with some areas appearing more concentrated and others more sparse.