MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 6 2001 Mr. Rob H. Hopkins Technical Director Metron Medical Australia P/L 57 Aster Avenue Carrum Downs, Victoria, Australia Re: K011955 Trade Name: Modification to: Accusonic Plus, Model AP-100 Regulation Number: 890.5300 Regulatory Class: II Product Code: IMI Dated: June 19, 2001 Received: June 22, 2001 Dear Mr. Hopkins: 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 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 (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 (QS) 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. 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. {1}------------------------------------------------ ## Page 2 - Mr. Rob H. Hopkins If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific arin vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m The caughestions on the promotion and advertising of your device, (201) 594-4639. Rudinonally, 2011 - 12:50 pm prease contact the Orifice or Compilation (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibility free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, BMitchellurd 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}------------------------------------------------ K011955 510 (k) NUMBER (IF KNOWN): DEVICE NAME: Accusonic Plus - AP100 ## INDICATIONS FOR USE: The indications for use are: - Relief or reduction of pain; 1. - Reduction of muscle spasm; 2. - Joint contracture; and 3. - 4. Local increase in circulation. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) BMutakee tro (Division Sign-Off) Division of General, Restorative and Neurological Devices KO11955 510(k) Number _