FORA TELEHEALTH SYSTEM

{0}------------------------------------------------ Attachment 8 ー ## JAN 1 6 2009 # 510 (k) Summary Submitter Information TaiDoc Technology Corporation Company name Contact person Yuhua Chen Address 6F, No 127, Wugong 2nd Rd , Wugu Township, Taiper County, 248, Tawan Phone (886-2) 6625-8188 FAX (886-2) 6625-0288 yuhua chen@taidoc com E-mail Date Prepared October 9th, 2008 2 Name of Device Trade Names Common Names Classification Names and Regulations FORA TeleHealth System Telemedicine system a) Radiofrequency physiological signal transmitter and receiver, Class II, 21CFR870 2910 b) Glucose Test System, Class II, 21CFR862 1345 c) Noninvasive Blood Pressure Measurement System, Class II, 21CFR870 1130, 3 Predicate Device Trade/Proprietary Name Common/Usual Name Submitter 510 (k) Number Carematix Wellness System Telemedicine system Carematix, Inc K031840 Trade/Proprietary Name BL Healthcare Remote Care Management system Common/Usual Name Telemedicine system BL Healtheare, Inc Submitter 510 (k) Number K051470 Page 1-of-3 K083046 p1/3 {1}------------------------------------------------ Page 2-of-3 #### 4 Device Description FORA TeleHealth System serves as the communication link between FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results, home users and healthcare professionals can do health management effectively #### 5 Intended Use The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The FORA TeleHealth System serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may ınclude healthcare professionals, other caregivers, or a disease management center The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results, home users and healthcare professionals can do health management effectively The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional This system is to be used or prescribed on the order of a physician {2}------------------------------------------------ Page 3-of-3 ## 6 Comparison to Predicate Device The FORA TeleHealth System is substantially equivalent to the Carematix Wellness System (K031840) and BL Healthcare Remote Care Management system (K051470) #### 7 Performance Studies Testing of FORA TeleHealth System and user evaluation indicate that the system meets the acceptable cnteria ## 8 Conclusion FORA TeleHealth System demonstrates satısfactory performance and ıs suitable for its intended use {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 5 - 2009 TaiDoc Technology Corporation c/o Ms. Yuhua Chen Assistant Manager 6F, No. 127, Wugong 2nd Rd., Wugu, Taipei County China Taiwan 248 Re: K083046 Trade/Device Name: FORA TeleHealth System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: November 27, 2008 Received: December 1, 2008 Dear Ms. Chen: This letter corrects our substantially equivalent letter of January 16, 2009. 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. {4}------------------------------------------------ Page 2 Ms. Yuhua Chen 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance 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 Manufacturers, 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, Arthister Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K083046 Attachment 1 ## Indications for Use 510(k) Number K083046 Device Name FORA TeleHealth System Indications for Use The FORA TeleHealth System is intended for use by patients remotely in combination with a variety of monitoring devices upon the prescription of healthcare professionals The system serves as the communication link between the FDA approved compatible devices and the server software at a compatible healthcare facility The healthcare facility may include healthcare professionals, other caregivers, or a disease management center The system is intended to gather and transmit patient data such as blood glucose, blood pressure and pulse rate via cable or wireless connections from patient to healthcare professionals at another facility The transmitted patient data is able to be reviewed and analyzed in this system Through evaluation of the historical test results. home users and healthcare professionals can do health management effectively The FORA TeleHealth System may not be used as a substitute for direct medical intervention or emergency care Interpretation of the information collected and transmitted requires clinical judgment by an appropnate healthcare professional This system is to be used or prescribed on the order of a physician Prescription Use _ X AND/OR (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CRH Office of Device Evaluation (ODE) Well 167 BZuckerman (Division Sign-Off) 1/16/09 Division of Cardiovascular Devices 610(k) Number K083046 Page 1 of 1 **510(k) Number** K083046 t