KINGTECH FOREHEAD THERMOMETER

{0}------------------------------------------------ ## KINGTECH ENTERPRISES LIMITED ROOM 2016. 20F., BLOCK B. REGENT CENTER, 70 TA CHUEN PING ST., KWAJ CHUNG. N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939 ## 510(K) SUMMARY ## for KINGTECH Forehead Thermometer, TF1265, TF1267 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(K) number is:__K 133113 | Submission Date: | September 22, 2013 | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Submitter: | Kingtech Enterprises Limited | | | | Room 2016, 20/F., Block B, Regent Center 70 Ta Chunen Ping<br>Street, Kwai Chung, New Territories, HK | | | | Tel: +852-24810188 Fax:+852-2423939 | | | Manufacturer: | Kingtech (Dong Guan) Enterprises Limited | | | | Farm Village, Da Ling Shan Town, DongGuan, China<br>Tel: +86-76985636260 Fax:+86-76985636350 | | | Establishment<br>Registration No.: | 3008808166 | | | Official Contact: | Dr. Jen, Ke-Min<br>Tel: +886-3-5208829 Fax:+886-3-5209783<br>Email: ceirs.jen@msa.hinet.net | | | Common /<br>Usual Name: | Forehead Thermometer | | | Trade Name: | KINGTECH Forehead Thermometer. Models: TF1265, TF1267 | | | Classification<br>Code: | FLL, Class II, 21 CFR 880.2910 | | | Intended Use: | TF1265, TF1267 Forehead Thermometer is an electronic<br>thermometer using an infrared sensor to detect human body<br>temperature fro the surface of human skin without contact.<br>It is for use by people of all ages in the homecare environment | | | Predicated<br>Devices: | K122221, Nexus IR30 Thermometer, Model: TD-1265<br>TaiDoc Technology Corporation | | | Device Description: | The Forehead Thermometer TF1265, TF1267 is characterized by<br>measuring human body temperature from the surface of human<br>skin. It utilizes infrared technology to measure infrared energy<br>emitted from the skin surface when making a temperature<br>measurement. | | | Test Principle: | The thermometer Measures temperature by reading infrared<br>radiation emitting from the skin and converts it into a temperature<br>value. | | {1}------------------------------------------------ ## KINGTECH ENTERPRISES LIMITED #### ROOM 2016, 20/P., BLOCK B, REGENT CENTER, 70 TA CHUEN PING ST., KWAI CHUNG, N.T. HONG KONG TEL : 852-24810188 FAX : 852-24253939 Performance Tests: Safety Test: · IEC 60601-1 - Medical electrical equipment Part 1. General requirements for safety, 2005. Electromagnetic Compatibility Test: · EN/IEC 60601-1-2 - Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007. In accordance with: EN12470, ASTME 1965-98, and ASTM E1112-00 This 510k submission only need change the application name of the predicate K122221 from "Nexus IR30 Thermometer, Conclusion: TD-1265" to "KINGTECH Forehead Thermometer, TF1265" there is the entire identical specifications and only need to separate into different 510k. And all of the test reports and documentation for this 510k submission were prepared by the applicant of the predicate device: TaiDoc Technology Corporation. We, Kingtech Enterprises Limited, are authorized by BioCare Co., Ltd. who is a branch office of TaiDoc Technology Corporation. We also present the authorized "Statement" as the following page. In addition, another model TF1267 of the subject device, it is only minor difference to the exterior dimension for the TF1265. Thus the new device is substantially equivalent to the predicate devices in this aspect. #### Clinical Tests: # Comparison and {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002 ### December 26, 2013 Kingtech Enterprises Limited C/O Dr. Ke-Min Jen Official Correspondent Room 2016, 20/F., Block B, Regent Center 70 Ta Chunen Ping Street Kwai Chung, New Territories HONG KONG Re: K133113 Trade/Device Name: KINGTECH Forehead Thermometer, Model: TF1265, TF1267 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: II . Product Code: FLL Dated: September 22, 2013 Received: September 30, 2013 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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, **Kwame O.** **Ulmer-S** for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K133113 ﺒﻪ، "ﻧﺎﺀ #### Device Name KINGTECH Forehead Thermometer, Models: TF 1265, TF 1267 #### Indications for Use (Describe) TF1265 and TF1267 Forehead Thermometer is an electronic thermometer using an infraced sensor to detect human body temperature fro the surface of human skin without contact. It is for use by people of all ages in the homecare environment. Type of Use (Select one or both, as applicable) [] Prescription Use (Part 21 CFR 801 Subpart D) χ Over-The-Counter Use (21 CFR 801 Subpart C) ## Please do not write below this line - continue on a separate page if needed. FOR FDA USE ONLY | Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Digitally signed by Richard C. Chapman<br>Date: 2013.12.26 11:50:34 -05'00' | |------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | FORM FDA 3881 (9/13) | Page 1 of 2 | {5}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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