SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a landscape with trees and a cloudy sky. The text "SUN-RAIN" is written in bold letters at the bottom of the image. The image appears to be a logo or a graphic design element, possibly for a company or product with a name related to sun and rain. KO90542 OCT 2 8 2009 ## 5. 510(K) SUMMARY # SUMMARY OF SAFETY AND EFFECTIVENESS for SUN-RAIN Ultrasonic Therapy | DATE OF SUBMISSION: | February 23, 2009 | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | SUBMITTER: | SUN-RAIN System Corp.<br>8F, No.125, Lane 235, Paochiao Road,<br>Sindian City, Taiwan, ROC, 23145<br>TEL: 886-2-89191180<br>FAX: 886-2-89191190 | ESTABLISHMENT REGISTRATION NO: 9616346 OFFICIAL Dr. JEN, KE-MIN CONTACT: No. 58, Fu-Chiun Street. Hsin-Chu City, TAIWAN, ROC, 30067 TEL: 886-3-5208829 FAX:886-3-5209783 TRADE NAME: SUN-RAIN Ultrasonic Therapy, SU-300, SU-400. SU-500, SU-600, SU-700, SU-800, SU-900 COMMON/USUAL Ultrasonic Therapy NAME: IMI, Class II CLASSIFICATION CODE: REGULATION 890.5300 NUMBER: PREDICATED DEVICE: SUN-RAIN Ultrasonic Therapy, SU-100 K024013 - INTENDED USE: The SUN-RAIN Ultrasonic Therapy generates 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. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "SUN-RAIN" in a bold, sans-serif font. Above the text, there is a blurry, pixelated area that appears to be a faded or obscured image. The text is the most prominent feature, suggesting it is the main subject of the image. Description of Ultrasonic equipment generates high frequency Device: sound waves that are transferred to a specific body area via a round-headed probe. The sound waves travel deep into tissue and create gentle heat. As the probe glides over the skin's surface, sound waves penetrate the skin's surface causing soft tissues to creating deep heat. In turn, the heat induces vasodilatation: drawing blood into the target tissues. The generated deep heat is found to help relieve pain and reduce muscle spasms. #### Non-Clinical Tests Submitted: The Ultrasonic Therapy equipment has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of ultrasonic physiotherapy equipment. The relevant standards including: - 1. IEC/EN 60601-1 : Medical electrical equipment Part 1. General requirements for safety, 1996. - 2. IEC/EN 60601-1-2 : Medical electrical equipment, Part 2. Electromagnetic compatibility -Requirements and tests, 2004. - 3. IEC 60601-2-5 : Safety particular requirements for ultrasonic physiotherapy equipment, 2005. #### None - 1. IEC 61689 : Ultrasonics Physiotherapy systems -Field specifications and methods of measurement in the frequency range. - 2. Reliability Test report. The subject new devices and the predicate device have the same indications for use and same power input. The major difference is new device of SU-400/SU-600/SU-800 is with 3MHz of frequency. Besides, the size and the dimension for the subject new devices are different. This is due to the different design and choice for the clients. Although the appearance and probe size are different but we use the same PCB and the specification is almost the This is not related to the safety same. or effectiveness. Thus the new device is substantially equivalent to the predicate devices in this aspect. - Clinical Tests Submitted: Performance Tests Submitted: Conclusion: {2}------------------------------------------------ Image /page/2/Picture/0 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 design featuring three overlapping, curved lines that resemble a bird in flight or a stylized human figure. The overall design is simple and conveys a sense of movement and progress. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 OCT 2 3 2009 SUN-RAIN System Corporation % ROC Chinese-European Industrial Research Society Dr. Ke-Min Jen No. 58, Fu Chiun Street Hsin Chu City, Taiwan, ROC 30067 Re: K090542 Trade/Device Name: SUN-RAIN Ultrasonic Therapy, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: September 30, 2009 Received: October 6, 2009 Dear Dr. Jen: 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 application (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. {3}------------------------------------------------ Page 2 - Dr. Ke-Min Jen 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CcntersOffices/CDRHOffices/ucm1117801cc11ccm11178001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Preu 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark M Millham Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use K_____________________________________________________________________________________________________________________________________________________________________________ 510(k) Number: Device Name: ... .... .. SUN-RAIN Ultrasonic Therapy, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 Indications for Use : The SUN-RAIN Ultrasonic Therapy generates 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. Prescription Use V (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) Concurrence of CDRH, Office of Device Evaluation (ODE) KATHLEEN M. HOGAN FOR M.MEKERSON (Division Sign of Surgical, Orthopedic, Divisionative Devices Page I of 1 510(k) Number