The Gaunying Infrared Lamp ( Model #: FIR 51, SN-51) are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Device Description

Gaunying Infrared Lamp (Model#: FIR 51, SN-51) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.

AI/ML Overview

The Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is intended to emit energy in the infrared spectrum to provide topical heating. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functional Performance: Ability to elevate tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; temporary increase in local blood circulation; and/or temporary relaxation of muscle (demonstrated by reaching an effective therapy temperature range).	Subject Device (FIR 51, SN-51): Skin temperature can rise to 40°C within 5 minutes and maintain skin temperature for at least 10 minutes within a 15-minute treatment time when tested at distances of 30cm, 35cm, and 40cm. Comparison with Predicate Device: Both the subject device and the predicate device (Xinfeng CQ-27, CQ-36, CQ-55A) achieved a temperature range of 41-45°C, which is considered an effective therapy temperature range. Testing was conducted at 30cm, 35cm, 40cm, and 45cm for the subject device (15 min treatment) and 8", 10", 12" for the predicate device (60 min treatment) in a 25°C ambient environment. The report states the new device is "as effective as" the predicate.
Electrical Safety: Compliance with relevant international standards.	Complies with IEC 60601-1 (1988 with amendments 1991, 1995), IEC 60601-1-2 (2001 with amendment 2004), and UL 60601-1 (2003).
Risk Management: All identified risks are under control.	A risk management report was submitted, showing "all the risk are under control." The device uses 600-2000 nm infrared (Near-infrared and Short-wavelength infrared), which is visible when working, implying a lower burn risk compared to the predicate device which uses 5-25 microns and is not visible.
Substantial Equivalence: The device is substantially equivalent to a legally marketed predicate device.	Compared to the Xinfeng Heating Lamp (K043558), the FIR 51, SN-51 has the same intended use. Differences in infrared wavelength (600-2000 nm vs 5-25 microns) are noted but are deemed not to affect effectiveness and imply a potentially lower burn risk for the subject device. The product passed safety testing and its risk management report showed all risks under control. Thus, the differences "do not raise new questions of safety and effectiveness."

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: The document describes "a performance testing with the subject device" and "a comparison testing with the subject device and predicate device." However, specific sample sizes (e.g., number of units tested, number of measurement points per unit) are not explicitly stated. Instead, it refers to conducting tests on "the subject device" at various distances.
Data Provenance: The tests were conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. The data appears to be retrospective relative to the 510(k) submission date, as the testing reports are cited within the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This section is not applicable as the evaluation primarily involved performance and safety testing against objective physical parameters (temperature measurements, compliance with electrical standards), not diagnostic interpretations requiring expert consensus. The "ground truth" for efficacy was established through demonstrating the ability to raise tissue temperature to a known therapeutic range.

4. Adjudication Method for the Test Set:

This section is not applicable as there was no expert review or adjudication of diagnostic findings. The tests involved direct physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This section is not applicable. The device is an infrared lamp for therapeutic heating, not a diagnostic imaging device involving human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This section is not applicable. The device is a physical therapeutic device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used was based on objective physical measurements (temperature readings) and established scientific understanding that a specific temperature range (41-45°C) is effective for the stated therapeutic purposes. Compliance with international electrical safety standards also served as a "ground truth" for safety.

8. The Sample Size for the Training Set:

This section is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable for the same reason as above.

Summary

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Gaunying Infrared Lamp FIR51,SN-51 510(K) Files: Section 5

AUG 1 3 2010

510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92

1.0 Submitter's Information

Establishment Registration Name:

Foshan Gaunying Electronics Co., Ltd.

4F, #4 Industry Country, Cheng Nan Park of Foshan Hi-tech Industrial Development Zone Foshan, Guangdong, China 528000

Contact Person of the Applicant:

Mrs. Ladi Lee GM

Foshan Gaunying Electronics Co., Ltd.

4F, #4 Industry Country, Cheng Nan Park of Foshan Hi-tech Industrial Development Zone Foshan, Guangdong, China 528000

Tel: +86-757-8310 7610 Fax: +86-757-8310 7621 Email: xhli@fseagle.com.cn

Contact Person of the Consultant:

Mr. Stephen Ling

MEDLAB (Shenzhen) Information Service Co., LTD

Room 2706, Block A. ZhongFang JinYuan Buiding, Xinwen Road Shenzhen, Guangdong, P.R. China, 518034

TEL: +86-755-83089699 FAX: +86-755-83089760

Email: lingbensuo@gmail.com, please CC sabrinawei@hotmail.com

Section 5, Page 1 of 4

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2.0 Device Information

Type of 510(k) submission:	Traditional
Device Common Name:	Infrared Lamp
Trade Name:	Infrared Lamp
Model:	FIR 51, SN-51
Classification name:	lamp, infrared, therapeutic heating
Review Panel:	Physical Medicine
Product Code:	ILY
Regulation Class:	Class II
Regulation Number:	21CFR 890.5500

3.0 Predicate Device Information

Sponsor:	Chongqing Xinfeng Medical Instrument Co., Ltd.
Device:	Xinfeng Heating Lamp, including 3 different models CQ-27, CQ-36 and CQ-55A
510(K) Number:	K043558

4.0 Device description

5.0. Intended Use

The Infrared Lamp are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

6.0 Performance Summary

Testing of the Infrared Lamp (Model#: FIR 51, SN-51) includes functional performance testing and electrical safety testing. The device is manufactured to comply with the following international standards:

IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements . for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General)
IEC 60601-1-2. Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment

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1:2004)). (General)

UL 60601-1, first edition, 2003, deviations to IEC 60601-1

7.0 Non-clinical data

We conduct a performance testing with the subject device. For the subject device, let a person at the distance 30cm. 35cm and 40cm. set the treatment time at 15 minutes, and then we use an electronic thermometer to measure the temperature of skin temperature every minutes. The testing result shows that the skin temperature can rise to 40□ within 5 minutes which means that the subject device can maintain skin temperature at least 10 minutes in one treatment time (15 minutes).

8.0 Comparison to predicate device and conclusion

Compared with predicate device Xinfeng CQ-27, CQ-36 and CQ-55A Heating Lamps made by Chongqing Xinfeng Medical Instrument Co., Ltd. (K043558), the device Infrared Lamp (Model#: FIR 51 and SN-51) has same intended use with the predicate device. Although, there is a little different technological characteristics:

The infrared wavelength used in subject device and predicate device is deferent. The subject device uses 600 nm - 2000 nm infrared, which belongs to Nearinfrared (0.75-1.4 um) and Short-wavelength infrared (1.4-3 um). The predicate device use 5 to 25 microns, which belongs to Long-wavelength infrared (8-15 um) and far infrared (15-1,000 um).

The human visible light is in wavelength 400–700 nm. So the subject device heating can be seen when it is working. The predicate device heating is not visible when it is working. That means the possibility of burns risk for subject device is less than the predicate device.

Whatever Near-infrared. Short-wavelength infrared. Long-wavelength infrared and Far infrared, they all can heat and therapy disease. The different wavelength will not affect the effectiveness of device.

We conduct a comparison testing with the subject device and predicate device. For the subject device, put an electronic temperature sensor at the distance 30cm. 35cm, 40cm and 45cm. Set the treatment time at 15 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 250. For the predicate device, put an electronic temperature sensor at the distance 8''. 10'' and 12''. Set the treatment time at 60 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 250. The result shows that both device can achive the temperature range 41-45 which is an effective therapy temperature range.

The testing report shows that Infrared Lamp (Model#: FIR 51 and SN-51) is as

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Gaunying Infrared Lamp FIR51,SN-51 510(K) Files: Section 5

effective as predicate device.

The new device pass the safety testing, and the risk management report shows all the risk are under control.

So, the deference does not raise new questions of safety and effectiveness. The Infrared Lamp (Model#: FIR 51 and SN-51), is substantially equivalent to the predicate device.

Submission date: Oct 21, 2009 9.0

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Foshan Gaunying Electronics Co., Ltd. % Intertek Testing Services NA, Inc. Mr. William J. Sammons 2307 E. Aurora Road Unit B7 Twinsburg, OH 44087

AUG 1 3 2010

Re: K102149

Trade/Device Name: Gaunying Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 29, 2010 Received: July 30, 2010

Dear Mr. Sammons:

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.

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

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Page 2 - Mr. William J. Sammons

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely vours.

Mark A. Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Gaunying Infrared Lamp FIR51,SN-51 510(K) Files: Section 4

Statement of Indications for Use

K102149

510(k) Number (if known):

AUG 1 3 2010

Device Name: Infrared Lamp Model: FIR 51, SN-51

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yurly A. Egorov
(Division Sign-Off)

Page 1 of 1

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102149

Section 4, Page 1 of 1

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.