Who is the manufacturer of Infrared Thermometer: Model YJ600?

Zhuhai Yueja Medical Device Technology Co., Ltd. filed the 510(k) submission for Infrared Thermometer: Model YJ600 (K232473).

What is the FDA product code for Infrared Thermometer: Model YJ600?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Infrared Thermometer: Model YJ600?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Infrared Thermometer: Model YJ600?

Infrared Thermometer, Model: RN-60A, RN-60B (K200471).

Who can help prepare an FDA 510(k) submission like Infrared Thermometer: Model YJ600?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Infrared Thermometer: Model YJ600

K232473 · Zhuhai Yueja Medical Device Technology Co., Ltd. · FLL · Feb 9, 2024 · General Hospital

Device Facts

Record ID	K232473
Device Name	Infrared Thermometer: Model YJ600
Applicant	Zhuhai Yueja Medical Device Technology Co., Ltd.
Product Code	FLL · General Hospital
Decision Date	Feb 9, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2
Attributes	Pediatric

Indications for Use

Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.

Device Story

Device is a non-contact infrared thermometer; inputs infrared radiation emitted from human forehead; transforms infrared energy via thermopile sensor and internal circuitry into digital temperature reading; displays result on LCD. Used in household or clinical settings by adults; operator points device at forehead (1-3 cm distance). Provides visual (backlight color) and audible (buzzer) feedback based on temperature range; aids clinical decision-making by identifying fever states. Benefits patient through non-invasive, rapid temperature monitoring.

Clinical Evidence

Clinical study included 200 subjects across four age groups (0-3 months, 3 months-1 year, 1-5 years, >5 years). Primary endpoint was clinical repeatability per ISO 80601-2-56 and ASTM E1965-98. Results demonstrated repeatability within ±0.3°C for all age groups, meeting standard requirements.

Technological Characteristics

Materials: ABS housing. Sensing: Infrared thermopile sensor. Energy: 2x AAA batteries. Form factor: Handheld. Connectivity: None. Sterilization: N/A. Standards: ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ASTM E1965-98, ISO 10993-5/10.

Indications for Use

Indicated for intermittent forehead body temperature measurement in all ages. Suitable for home and clinical use.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

Infrared Thermometer, Model: RN-60A, RN-60B (K200471)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. February 9, 2024 Zhuhai Yueja Medical Device Technology Co.,Ltd. Feng Yan Department manager Room 201, Building 2, No.2 Liushi Road Tangjiawan Town, High-tech Zone Zhuhai, Guangdong 519000 China Re: K232473 Trade/Device Name: Infrared Thermometer: Model YJ600 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 11, 2024 Received: January 11, 2024 Dear Feng Yan: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, {2}------------------------------------------------ General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232473 Device Name Infrared Thermometer: Model YJ600 Indications for Use (Describe) Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | | | Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K232473- 510(k) Summary - Device Submitter: Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone, Zhuhai, 519000, China - Contact Person: Feng Yan Department Manager Phone: +86-18826906029 E-mail: fengy@myzr.com.cn Date Prepared February 9, 2024 # l Subject Device | Trade Name of Device: | Infrared Thermometer: | |-----------------------|---------------------------------| | | Model YJ600 | | Regulation Number: | 21 CFR 880.2910 | | Product Code: | FLL | | Regulation Name: | Clinical Electronic Thermometer | | Common name | Electronic Thermometer | | Regulatory Class | II | | Review Panel | General Hospital | ### II Predicate Device | 510k Number | K200471 | |-----------------------|---------------------------------| | Trade Name of Device: | Infrared | | | Thermometer, Model: | | | RN-60A, RN-60B | | Regulation Number: | 21CFR 880.2910 | | Regulation Name: | Clinical electronic thermometer | | Regulatory Class | II | | Product Code: | FLL | ### III Device Descriptions Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator {5}------------------------------------------------ should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature. # IV Indications for use Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers. # V Technological Characteristics Comparison VI-1: Comparison of Subject and Predicate Devices | Device Characteristic | Subject Device | Predicate Device (K200471) | Discussion | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Type of Thermometer | Infrared Thermometer: Model YJ600 | Infrared Thermometer, Model: RN-60A, RN-60B | - | | Product Code | FLL | FLL | Same | | Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | | Class | II | II | Same | | Indications for Use | Infrared Thermometer is intended for the intermittent measurement of body temperature from forehead on people of all ages. It can be used by Consumers in household environment and by health care providers. | The Infrared thermometer is a non-contact infrared thermometer intended for intermittent the measurement of all human body temperature from the forehead for people of one month old and above. The device is reusable for home use and clinical use. | Different 1 | | Patient population | All ages | One month old and above | Different 2 | | Operation Principle | According to the characteristics of natural objects, all objects with temperatures higher | The Infrared Thermometers RN-60A and RN-60B measure the | Different 3 | | | | | | | | zero (-273.15 °C ) are constantly emitting infrared capabilities to surrounding space. Its radiation characteristics, radiation energy and wavelength distribution are closely related to the surface temperature of the object. The human body, like other organisms, radiates infrared energy around itself, and its wavelength is generally 9-14µm, which is in the infrared band of 0.76-100 μ m. Because the light in this wavelength range is not absorbed by air, the infrared radiation from human body has nothing to do with the environmental impact, but only with the energy released by human body. | temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero and will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. | | | Prescription/over-the-counter use | over-the-counter use | over-the-counter use | Same | | Measurement technology | Infrared radiation detection that converts a user's forehead temperature using | Infrared radiation detection that converts a user's | Same | | | the infrared energy emitted in the area around the user's forehead to a reference site equivalent temperature. | forehead temperature using the infrared energy emitted in the area around the user's forehead to a reference site equivalent temperature. | | | Measurement site | Forehead | Forehead | Same | | Measurement Range | $22.0 °C~42.9 °C$ | Forehead mode: $32.0°C ~42.9°C$ (89.6 to 109.2 ° F) | Different 4 | | Accuracy | $±0.3°C$ | Forehead mode: $±0.2°C (0.4°F)$ within (96.8°F ~ 102.2°F), $±0.3°C(0.5°$ F) when $<36.0°C$ (96.8°F) and > $39.0°C$ (102.2°F) | Different 5 | | Display resolution | $0.1°C$ | $0.1°C(0.1°F)$ | Same | | C/F switchable | Yes | Yes | Same | | Measurement distance | 1-3 cm | 3~5 cm | Different 6 | | Measurement time | 2s | 1s | Different 7 | | Sensor type | high precision infrared sensor | Thermopile | Different 8 | | Memory | 32 sets | 60 sets | Different 9 | | Buzzer | Yes | Yes | Same | | Auto power-off while no operation | Yes | Yes | Same | | Power supply | 2 AAA size batteries | 2*AAA battery | Same | | Display screen | LCD | LCD | Same | | Operation Environment | +15°C~+40C RH<95% non-condensing,70kPa~106k Pa | $5.0°C~40.0°C$ (41°F~104°F) 15%≤RH≤90% 70.0kPa-106.0kPa | Different 10 | | Storage Environment | -20°C~+55°C humidity<93%, 70kPa~106kPa | -25.0℃~70.0°F (-13°F~158°F) RH≤95% 50.0kPa-106.0kPa | Different 11 | | Conformance standard | ISO80601-2-56 (performance), IEC60601-1(Safety), IEC60601-1-2(EMC) IEC 60601-1-11(Home use) ASTM E1965-98 IEC60601-1-6(Usability) | ISO80601-2-56 (performance), IEC60601-1(Safety), IEC60601-1-2(EMC) IEC 60601-1-11(Home use) ASTM E1965-98 | Same | | Patient contact materials | ABS | ABS | Same | | Biocompatibility | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Different 1 There are minor differences in the wording of the indications for use. In addition, the subject device is indicated for people of all ages, while the predicate device is indicated for people one month old and above. Clinical accuracy testing was conducted to ISO80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness. ### Different 2 The subject device is indicated for people of all ages, while the predicate device is indicated for people one month old and above. Clinical accuracy testing was conducted to ISO80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness. ### Different 3 The description of operation principle is different. However, its working principle is the same, both use the principle of receiving infrared rays to measure the temperature of the human body. Therefore, the difference does not raise different questions of safety and effectiveness. ### Different 4 The minimum measurement temperature of the subject device is lower than that of the predicate device. Performance testing was conducted to ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness. ### Different 5 The accuracy is different, however compliant with ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness. {9}------------------------------------------------ #### Different 6 The measurement distance is different; however, performance testing was conducted to demonstrate the difference does not raise different questions of safety and effectiveness. #### Different 7 The measurement time is different; however, performance testing was conducted to demonstrate the difference does not raise different questions of safety and effectiveness. #### Different 8 The sensor type is different; however, performance testing was conducted to demonstrate the difference does not raise different questions of safety and effectiveness. #### Different 9 The memory is different; however, the difference does not raise different questions of safety and effectiveness. #### Different 10 The operation environment is different, however compliant with ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness. #### Different 11 The storage environment is different, however compliant with ISO 80601-2-56. Therefore, the difference does not raise different questions of safety and effectiveness. ### VI Summary of Non-clinical Testing (Bench) The non-clinical testing for Infrared Thermometer: Model YJ600 was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. | Inspecting item | | Inspection content and acceptance standard | Result | | |----------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | 1. Appearance and structure test | 1.1 | The shape of the thermometer should be correct, the surface should be smooth and clean, and there should be no obvious scratches, sharp edges, burrs and deformation. | Pass | | | | 1.2 | The text and symbols on the thermometer control panel and function keys should be clear, accurate and firm. | Pass | | | | 1.3 | The control devices of the thermometer should be flexible and reliable, and the fasteners should not | Pass | | | | | | he loose. | | | | 1.4 | | The top of the thermometer probe should be smooth and the edges should be free of burrs. | Pass | | | 1.5 | | The function keys of the thermometer should be clearly marked, indicating that the function keys of the thermometer should be clearly marked and indicated. | Pass | | 2. Temperature range test | display | | In body temperature mode, the temperature display range of the thermometer $22.0°C~42.9°C$ | Pass | | 3. Maximum allowable error test | | | The maximum allowable error of the thermometer is $\pm 0.3° C$ within the temperature display range of $22.0° C$ to $42.0°C$ . | Pass | | 4. Anti-drop test | | | The thermometer shall meet the requirements of 6.3.1 after falling freely from a height of 1m in vertical distance to a hard surface with three different initial postures during normal use. | Pass | | 5. Indicative unit test | 5.1 Resolution | | The resolution of the indication unit of the thermometer is $0.1°C$ ( $0.1° F$ ). | Pass | | | 5.2 Display | | The height of the reading value on the thermometer display is >4mm. | Pass | | | 5.3 Prompt function | | In the body temperature mode, when the measured value of the thermometer is lower than $22.0°C$ , there should be a prompt sound "Di di" twice and "LO" should be displayed; when the measured value is higher than $42.9°C$ , a prompt sound " Beep" twice and display "HI" | Pass | | | 5.4 Low | The battery of the voltage | Pass | | | | voltage | thermometer is lower than 2.5±0.2V. | | | | | prompt | " icon flashes on When the " | | | | | function | | | | | | | the screen, it means that the battery | | | | | | is low and needs to be replaced. | | | | | 5.5 Mode | a) The thermometer should have a | Pass | | | | | temperature measurement mode. | | | | | | The calibration mode b) for | | | | | | calibration purposes shall be | | | | | | obtained by a conversion technique | | | | | | directly sets the infrared that | | | | | | thermometer to this mode. | | | | 6 Function and | 6.1 Unit | The thermometer has a temperature | Pass | | | performance | switching | unit switching function, which can | | | | test | function | switch between "℃" and "F". | | | | | 6.2 Sound | a) In body temperature mode, when | Pass | | Table VII-1: Performance testing was conducted on the subject device {10}------------------------------------------------ {11}------------------------------------------------ | Prompt Function | the measurement result is in the range of 22° C to 37.4°C, a green backlight will be displayed and a short sound will arise. b) In body temperature mode, when the measurement result is in the range of 37.5° C to 38.4° C, an orange backlight will be displayed and 1 long sound + 3 short sounds will arise. c) In body temperature mode, when the measurement result is in the range of 38.5° C to 42.9° C, a red backlight will be displayed and 1 long sound + 5 short sounds will arise. | | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | 6.3 Measuring time | The thermometer should complete the temperature measurement within 2s. | Pass | {12}------------------------------------------------ | | 6.4 Memory query | 32 groups of local data can be queried. | Pass | |-------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------| | 7. Cleaning and disinfection test | | After the thermometer is cleaned/disinfected according to the instructions in the instruction manual, it shall meet the requirements of 6.3.1. | Pass | | 8. Self-inspection function test | | All LCDs on the screen should be fully displayed every time the thermometer is turned on. | Pass | | 9. Automatic shutdown function test | | In standby mode, when there is no button action, it will automatically shut down within 20 seconds. | Pass | | 10. Instruction Manual Inspection | | The instructions for use of the thermometer shall at least include the following: | Pass | | 11. Electrical safety inspection | 11.1 | a) Temperature display range, temperature unit, maximum allowable error, normal working and storage conditions. b) Conversion method between calibration mode and body temperature mode; c) The clinical accuracy or clinical bias of the subject population, body part and thermometer. | Case Leakage Current and Patient Leakage Current: | Pass | | | | | | | |----------------------------------------|------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------|--|--|--|--|--|--| | | | | Test item Normal status Case leakage current <100uA Patient d.c <10uA | | | | | | | | {13}------------------------------------------------ | | | leakage (BF) | a.c | <100uA | | |--------------------------|------|--------------------------------------------------------------------------------------------------------------------|-----|--------|------| | | 11.2 | Dielectric Strength: Dielectric strength, apply 500Vd.c., the device under test should not be broken down | | | Pass | | 12. Packaging inspection | | The actual product is consistent with the packing list, and the content on the nameplate is correct. | | | Pass | # Others test: | ID# | Test | Method | Acceptance Criteria | Conclusion | |-----|-----------------------------------------------------------|-------------------|--------------------------------------|------------| | 1 | Performance test | ASTM E 1965-98 | Meet the requirement of the standard | Pass | | | | ISO 80601-2-56 | Meet the requirement of the standard | Pass | | 2 | Electromagnetic Compatibility and Electrical Safety | IEC 60601-1 | Meet the requirement of the standard | Pass | | | | IEC 60601-1-2 | Meet the requirement of the standard | Pass | | | | IEC 60601-1-11 | Meet the requirement of the standard | Pass | | | | IEC/TR 60601-4-2 | Meet the requirement of the standard | Pass | | 3 | Usability Test | IEC 60601-1-6 | Meet the requirement of the standard | Pass | | 4 | Biocompatibility Testing (skin contact < 24h) | | | | | 4.1 | In Vitro Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Pass | | 4.2 | Skin Sensitization Test | ISO 10993-10:2010 | Non-sensitizer | Pass | | 4.3 | Skin Irritation Test | ISO 10993-10:2010 | Non-Irritation | Pass | {14}------------------------------------------------ # VII Clinical Test Conclusion YJ600 was tested to ISO 80601-2-56:2017/Amd 1:2018 Medical electrical equipment --Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement — Amendment 1 and ASTM E1965-98(Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. This study included 200 subjects (the age range include 0 up to 3 months to one year, older than one year to five years, older than five years, detail groups as below) | Age group | Age Range | Number | Gender distribution | | | |-----------|-----------------------------------|--------|---------------------|--------|------------| | | | | Gender | Number | Percentage | | A | 0 up to 3 months | 50 | Female | 22 | 44% | | | | | Male | 28 | 56% | | B | 3 months to one year | 50 | Female | 23 | 46% | | | | | Male | 27 | 54% | | C | older than one year to five years | 50 | Female | 28 | 56% | | | | | Male | 22 | 44% | | D | older than five years | 50 |…

Infrared Thermometer: Model YJ600

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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Infrared Thermometer: Model YJ600

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Indications for Use

Device Story

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Indications for Use

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Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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