Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603

• K Number: K203707
• Device Name: Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
• Manufacturer: ShenZhen ZhengKang Technology Co., Ltd.
• Date Cleared: 2021-03-12 ( 84 days)
• Product Code: FLL
• Regulation Number: 880.2910

Intended Use

The Infrared forehead thermometer (Models JZK-602, JZK-603) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

Device Description

Infrared forehead thermometers (includes model JZK-602, JZK-602, JZK-603) are intended to measure the body temperature through receiving infrared energy radiation via the forehead for people of all ages. These thermometers have the capability to measure temperature via body mode or object mode, and the temperature is directly shown on the LCD display. These thermometers have the following features: 1) The device is intended to be reusable for home use and clinical use. 2) The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, LCD display. 3) Switching of temperature unit between °C and °F. 4) The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results. 5) Buzzer on or off to set the prompt tone on or off. 6) Prompt tone function and backlights function. 7) The prompt limit setting function. 8) Low battery indication, and auto power-off.

Predicate Devices

K191251

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard infrared temperature measurement technology and do not mention any AI or ML components or capabilities.

Therapeutic

No
A therapeutic device is used to treat a disease or condition. This device is a thermometer, which is used for measurement, not treatment.

Diagnostic

Yes
The device is an infrared forehead thermometer intended for the intermittent measurement of human body temperature, which is a diagnostic measurement.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an infrared sensor, signal receiving processor, keys, buzzer, and LCD display.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
• Device Function: The Infrared forehead thermometer measures human body temperature by receiving infrared energy radiation from the forehead. This is a non-invasive measurement taken on the body, not a test performed on a sample taken from the body.
• Intended Use: The intended use is for the intermittent measurement of human body temperature, which is a physiological measurement, not a diagnostic test on a biological sample.

Therefore, based on the provided information, the Infrared forehead thermometer is a medical device, but it falls under a different category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Infrared forehead thermometer (Models JZK-602, JZK-603) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

Infrared forehead thermometers (includes model JZK-602, JZK-602, JZK-603) are intended to measure the body temperature through receiving infrared energy radiation via the forehead for people of all ages. These thermometers have the capability to measure temperature via body mode or object mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:

• The device is intended to be reusable for home use and clinical use.
• The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, LCD display.
• Switching of temperature unit between °C and °F.
• The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
• Buzzer on or off to set the prompt tone on or off.
• Prompt tone function and backlights function.
• The prompt limit setting function.
• Low battery indication, and auto power-off.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Forehead

Indicated Patient Age Range

People of all ages.

Intended User / Care Setting

Reusable for home use and clinical use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The clinical study is conducted as the requirement of ASTM E1965-98 (Reapproved 2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98(Reapproved 2016).

The clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation. The clinical study evaluated 200 subjects, and the infrared forehead thermometer was evaluated in all age groups. All subjects were divided into three age groups, including (1)Infants newborn to one year, (2)Children - greater than one to five years; (3)Adults - greater than five years old. 50 newborns 0 up to 3 months, 50 infants older than 3 months up to 1 year, 50 children older than 1 year and younger than 5 years, and 50 people older than 5 years are selected. The clinical test report showed the clinical performance of the subject devices complied with the requirement of ASTM E1965-98(Reapproved 2016).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191251

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.

Summary

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March 12, 2021

ShenZhen ZhengKang Technology Co., Ltd. % Iris Wang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China

Re: K203707

Trade/Device Name: Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: December 8, 2020 Received: December 18, 2020

Dear Iris Wang:

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.

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

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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 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-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 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-device-safety/medical-device-reportingmdr-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/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 ([e-mail]) or phone [phone] 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203707

Device Name

Infrared Forehead Thermometer, Model JZK601, JZK602, JZK603

Indications for Use (Describe)

The Infrared forehead thermometer (Models JZK-602, JZK-603) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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

Date Prepared	March 10, 2021
Manufacturer	ShenZhen ZhengKang Technology Co., Ltd.
Address:
2&3/F, Building A, No.3 FuXing Yi Lane, HeHua Community,
PingHu Street, LongGang District, ShenZhen, GuangDong,
China.
Contact person: Huayong Yang
TEL: [phone]
E-Mail: [e-mail]
Submission
Correspondent	Shenzhen Joyantech Consulting Co., Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian
Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong
Province, China.
Contact person: Ms. Iris Wang; Mr. Field Fu
E-Mail: [e-mail]; [e-mail]
Image: [logo]
Establishment
registration number	3015697152

2. Device Information

Device Name:	Infrared Forehead Thermometer
Model:	JZK-601, JZK-602, JZK-603
Classification Name:	Thermometer, Electronic, Clinical
Review Panel:	General Hospital
Device Class:	2
Regulation Number:	880.2910
Product Code:	FLL

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3. Predicate Device

Manufacturer:	Shenzhen Calibeur Industries Co., Ltd.
Device Name:	Infrared Thermometer
Model:	DT-8836T, DT-8836P
510(k) Number:	K191251
Regulation Number:	880.2910
Product Code:	FLL

4. Device Description

Infrared forehead thermometers (includes model JZK-602, JZK-602, JZK-603) are intended to measure the body temperature through receiving infrared energy radiation via the forehead for people of all ages. These thermometers have the capability to measure temperature via body mode or object mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:

• The device is intended to be reusable for home use and clinical use. 1)
• The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, 2) LCD display.
• 3. Switching of temperature unit between °C and °F.
• The latest 32 sets of memory for measuring human body and object; the user can view or delete 4) the previous measurement results.
• 5. Buzzer on or off to set the prompt tone on or off.
• 6. Prompt tone function and backlights function.
• 7. The prompt limit setting function.
• Low battery indication, and auto power-off. 8)

5. Intended Use/ Indications for Use

The Infrared forehead thermometer is a non-contact infrared thermometer (Models JZK-601, JZK-602, JZK-603) intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

6. Comparison with Predicate Device

The subject device infrared forehead thermometer, Model: JZK-602, JZK-603 is substantially equivalent to the predicate device (K191251). This conclusion is based upon comparison on intended use, technological characteristics, materials and applicable safety standards. The difference between the subject device and predicate device do not raise any issues on the device safety and effectiveness.

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| Items | Subject Device (K203707)
(Model: JZK-601, JZK-602,
JZK-603) | Predicate Device (K191251) | Comparison |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Regulation number | 880.2910 | 880.2910 | Same |
| Product code | FLL | FLL | Same |
| Intended Use/
Indications for use | The Infrared forehead
thermometer (Models JZK-
601, JZK-602, JZK-603) is a
non-contact infrared
thermometer intended for the
intermittent measurement of
human body temperature from
forehead at a distance of 1-
5cm for people of all ages.
The device is reusable for
home use and clinical use. | The Infrared thermometer is a
non-contact infrared
thermometer intended for the
intermittent measurement of
human body temperature from
forehead for people of all
ages. The device is reusable
for home use and clinical use. | Comparable
(1) See below |
| Measurement Method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement Range | 32 - 42.9°C (89.6 - 109.2°F) | 32.0 - 42.5°C (89.6 - 108.5°F) | Comparable
(2) See below |
| Accuracy | ±0.3°C(0.5°F) within 32 -
34.9°C (89.694.8°F)
±0.2°C (0.4°F) within 35 -
42°C (95.0107.6°F)
±0.3°C(0.5°F) within 42.1 -
42.9°C (107.8~109.2°F) | ±0.2°C (0.4°F) within 35.0°C -
42.0°C (95.0°F ~ 107.6°F),
±0.3°C(0.5°F) other range | Same |
| Display | 0.1°C /0.1°F | 0.1°C(0.1°F) | Same |
| Measurement
distance | 1-5cm | ≤3cm | Comparable
(3) See below |
| Measurement place | Forehead | Forehead | Same |
| Response time | ≤3 seconds | 1s | Comparable
(4) See below |
| Sensor type | Thermopile | Thermopile | Same |
| Scale Selection | °C /°F | °C /°F | Same |
| Memory | 32 sets | 60 sets | Comparable
(5) See below |
| Buzzer | Yes | Yes | Same |
| Shelf Life | 5 years | Not Available | Acceptable (6)
See below |
| IP classification | IP22 | Not Available | Acceptable (6)
See below |
| Auto power-off while
no operation | Yes | Yes | Same |
| Power supply | JZK-601 and JZK-603: DC 3V
(2× AA 1.5V Alkaline
batteries)
JZK-602: DC 3V (2× AAA) | 2 * 1.5V AAA | Comparable
(7) See below |
| | 1.5V Alkaline batteries) | | |
| Display screen | LCD | LCD | Same |
| Contact materials | ABS | ABS | Same |
| Backlight | JZK-601 and JZK-603:
Three color backlight (green,
yellow, and red)
JZK-602: two color backlight
(green and red) | Not Available | Acceptable (6)
See below |
| Operation
Environment | 10 - 40°C (50 - 104°F)
Humidity:≤95% | 10 - 40°C (50 - 104 °F)
RH 15 - 95% | Comparable
(8) See below |
| Storage Environment | -20 - 60°C (-4 - 140°F)
Humidity: ≤95% | -25 - 55°C (-13 - 131°F)
RH:15 - 95% | Comparable
(9) See below |
| Dimension | JZK-601 and JZK-603:
154 x 96 x 42mm
JZK-602: 143 x 81 x 36mm | 153.8 x 62.4 x 62.4 mm | Comparable
(10) See below |
| Weight | JZK-601 and JZK-603: 93g
JZK-602: 86g | 96g | Comparable
(10) See below |
| Conformance
standard | ISO80601-2-56 (performance)
IEC60601-1(Safety),
IEC60601-1-2(EMC)
ASTM E1965-98 | ISO80601-2-56 (performance)
IEC60601-1(Safety),
IEC60601-1-2(EMC)
ASTM E1965-98 | Same |
| Patient contact
materials | ABS | ABS | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |

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Discussion of Comparable Items:

(1) Indications for Use

The subject device indications for use includes the models and measurement distance. Therefore, this difference does not affect the performance and accuracy

(2) Measurement Range

The measurement range of subject device is different from the predicate device. The performance testing shows that the subject device complies with the performance standard ISO 80601-2-56 and ASTM E1965-98. Therefore, this difference does not affect the performance and accuracy.

(3) Measurement distance

The measurement distance of subject device is a little different from the predicate device. The performance testing shows that the subject device complies with the performance standard ISO 80601-2-56 and ASTM E1965-98. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

Page 4 of 7

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(4) Response time

The response time of subject device is different from the predicate device. However, the software has been validated according to FDA's software guidance. The performance testing shows that the subject device complies with performance standard during performance testing ISO 80601-2-56 and ASTM E1965-98 and clinical testing. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

(5) Memory

The memory of subject device is different from predicate device. The software function of memory of subject device has been verified during software verification according to FDA's software guidance, and the performance testing shows that the subject device complies with performance standard ISO 80601-2-56 and ASTM E1965-98performance and clinical testing. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

(6) Shelf Life, IP Classification, Backlight

The shelf life, ingress protection, and backlight of the predicate were not available. However, the device is comparable to other devices on the market. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

(7) Power supply

The power supply of subject device for model: JZK-602 is the same with the predicate device, but the power supply of subject device for model: JZK-601/JZK-603 is different from the predicate device. However, the both of the subject device has been demonstrated to comply with the requirements of electrical safety IEC 60601-1 and Electromagnetic Compatibility IEC 60601-1-2. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

(8) Operation Environment

The operation environment of subject device is different from the predicate device, but the measurement accuracy of subject device has been demonstrated to comply with the requirements of standards IEC 60601-1 and ISO 80601-2-56 in operation environment. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

(9) Storage Environment

The operation and storage environment of subject device is different from the predicate device, but the subject device has been demonstrated to comply with the requirements of standards IEC Page 5 of 7

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60601-1 and ISO 80601-2-56. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

(10) Dimension, Weight

The dimension and weight of subject device is different from the subject device. The difference is caused by their different appearance and construction, but the electrical safety, electromagnetic compatibility, performance of subject device has been evaluated to meet the requirements of the standards IECS60601-1, IEC 60601-1-2, ASTM E1965-98 and ISO 80601-2-56. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

7. Non-Clinical Test Summary

7.1. Electromaqnetic Compatibility and Electrical Safety Test

The subject device has been tested in compliance with the following standards: 1) AAMI/IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2. IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

3. IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

7.2. Biocompatibility Test

The subject device has been tested in compliance with the following standards:

1. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

• 2. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

7.3. Performance Test-Bench

The subject device has been tested in compliance with the following standards:

1. ISO 80601-2-56:2017+AMD2018 Medical electrical equipment - Part 2-56: Particular

requirements for basic safety and essential performance of clinical thermometers for

body temperature measurement

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2. ASTM E1965-98 (Reapproved 2016) Standard Specification for InfraredThermometers for Intermittent Determination of Patient Temperature

7.4. Software Verification

The software documentation of the subject device was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005.

8. Clinical Study

The clinical study is conducted as the requirement of ASTM E1965-98 (Reapproved 2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98(Reapproved 2016).

The clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation. The clinical study evaluated 200 subjects, and the infrared forehead thermometer was evaluated in all age groups. All subjects were divided into three age groups, including (1)Infants newborn to one year, (2)Children - greater than one to five years; (3)Adults - greater than five years old. 50 newborns 0 up to 3 months, 50 infants older than 3 months up to 1 year, 50 children older than 1 year and younger than 5 years, and 50 people older than 5 years are selected. The clinical test report showed the clinical performance of the subject devices complied with the requirement of ASTM E1965-98(Reapproved 2016).

9. Conclusion

The subject device Infrared Forehead Thermometer (Model: JZK-601, JZK-602, JZK-603) is substantially equivalent to the predicate device (K191251). This conclusion is based upon comparison on intended use, technological characteristics and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.