February 10, 2021 Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. ℅ Yoyo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town Shenzhen, Guangdong 518000 China Re: K201536 Trade/Device Name: Infrared Forehead Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 28, 2020 Received: January 4, 2021 Dear Yoyo Chen: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.2 2 Silver Spring, MD 20993 www.fda.gov K201536 - Yoyo Chen Page 2 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting- mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical- devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure K201536 510(k) Summary This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92. 1. Administrative Information Submission Date February 10, 2021 Manufacturer Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. information Address: No.688 Dong'an 1st Road, Xintang Street, Xiaoshan District, Hangzhou,China 311200 Contact person: Jenny TEL: +86(0571) 82623931 E-Mail: [email protected]; Submission Shenzhen Joyantech Consulting Co., Ltd. Correspondent 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong Province, China. 518000 Contact person: Ms. Yoyo Chen TEL:+86(755) 86069197 E-Mail: [email protected]; [email protected] Establishment registration number 3016658659 2. Device Information Device Name: Infrared Forehead Thermometer Model: QY-EWQ-02 Classification Name: Clinical Electronic Thermometer (Infrared Thermometer) Review Panel: General Hospital Device Class: 2 Regulation Number: 21 CFR 880.2910 Product Code: FLL Page 1 of 7 3. Predicate Device Manufacturer Microlife Intellectual Property GmbH Device name Microlife Non-Contact Infrared Forehead Thermometer Model FR1DG1 (NC200) 510(K) Number: K191829 Product Code FLL 4. Device Description The infrared forehead thermometer, Model of QY-EWQ-02 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home. The infrared forehead thermometer has the following features: 1) This device can be used for measuring the forehead temperature; 2) Body and object temperature switching 3) Two temperature unit conversion, °C or °F; 4) LCD display with backlight; 5) Automatic range selection; resolution is 0.1°C (0.1°F) 6) The latest 20 measurement data can be memorized and stored; 7) Three color backlight display (Red, Orange, Green); 8) Low battery detection; 9) Turn on/off the prompt tone; 10) High temperature alarm limit setting; 11) Ambient temperature detection; 12) Malfunction indication; 13) Low and high temperature alarm 5. Indication for Use The infrared forehead thermometer is non-sterile, reusable, non-contact and handheld device for the intermittent measurement and monitoring of human body temperature from the center of the forehead from a measurement distance of 3-5 cm. It can be used by consumers in homecare environment and doctors in clinic. It is intended for measuring human body temperature of people of all ages. 6. Comparison with predicate device The subject device Infrared Forehead Thermometer (Model QY-EWQ-02) is substantially equivalent to the predicate device (K191829). The comparison of technological characteristics between the subject device and predicate device is listed as follows: Page 2 of 7 Items Subject Device Predicate Device Comparison (K201536) (K191829) Intended use The infrared forehead The Microlife Non-Contact Same thermometer is intended for Infrared Forehead the intermittent measurement Thermometer, Model and monitoring of human FR1DG1 (NC200) is intended body temperature. The device for the intermittent is indicated for use by people measurement and monitoring of all ages in the home. of human body temperature. The device is indicated for use by people of all ages in the home. Thermometer Infrared thermometer Infrared thermometer Same type Non-contact Non-contact Device Infrared radiation detection Infrared radiation detection Same Measurement Technology Measurement Forehead Forehead Same location Measurement 32.0°C ~43.0°C 32.0°C ~43.0°C Same Range (89.6°F～109.4°F); (89.6°F～109.4°F); Measurement ±0.2 °C: 32.0°C ~ 43.0 °C ±0.2 °C: 35.0 ~ 42.0 °C Different accuracy ±0.4 °F: 89.6°F～109.4°F ±0.3 °C: 34°C ~ 34.9°C, (Note 1) 42.1°C ~43°C, ±0.4 °F: 95.0 ~ 107.6 °F, ±0.5 °F: 93.2 ~94.8 °F， 107.8~109.4 °F Clinical ≤0.2 °C (0.4 °F) unknown Different Repeatability (Note 1) Temperature 3 to 5 cm Appropriate within 5 cm Similar Measurement distance Display Type LCD Display LCD Display Same Display Same 0.1°C( 0.1°F) 0.1°C( 0.1°F) resolution Power supply DC 3V(2x 1.5V AAA DC 3V (2x 1.5V AAA batteries) Same batteries) Measurement ≤ 1second ≤ 3 second Different time (Note 2) Measurement 20 sets memories 30 sets memories Different data memories (Note 3) Page 3 of 7 Items Subject Device Predicate Device Comparison (K201536) (K191829) Beeper setting Yes Yes Same Date and time Different No Yes setting (Note 4) Backlight Green, yellow and red Green and red backlight Different backlight according to the according to the measured (Note 5) measured temperature; temperature; Auto-off time Approx. 13 seconds after last Approx. 1 minute after last Different measurement