(15 days)
Not Found
No
The device description and performance studies focus on basic hardware components, time setting via software, and temperature measurements, with no mention of AI or ML algorithms.
Yes.
The device's intended use is to provide topical heating for the temporary relief of minor muscle and joint pain and stiffness, muscle spasm, and to temporarily increase local blood circulation and relax muscle, directly indicating therapeutic effects.
No
This device is an infrared lamp intended for therapeutic purposes (topical heating for pain relief, increased circulation, muscle relaxation) by emitting infrared energy, not for diagnosing medical conditions.
No
The device description clearly states it is a physical infrared lamp with a built-in Halogen lamp, plastic enclosure, ceramic/glass plating, power switch, time setting button, power supply, fuse, thermal protector, and cooling fan. While it mentions software controls the treatment time, the core of the device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the body for therapeutic purposes (pain relief, increased blood circulation, muscle relaxation). This is a physical therapy or pain management application, not a diagnostic one.
- Device Description: The description details a lamp that emits infrared light to heat tissue. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is a therapeutic device that uses infrared light for heating, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Infrared Lamp is 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.
Product codes
ILY
Device Description
Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is a non-invasive, portable infrared lamp designed to deliver light energy in the infrared spectrum to the target tissue. The light energy is emitted by a built-in Halogen lamp. rated 110-130 Vac. which is enclosed by plastic enclosure, except front panel which is a ceramic / glass plating.
Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display.
The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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
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 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)). (General)
- UL 60601-1, first edition, 2003, deviations to IEC 60601-1 .
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 400 within 5 minutes which means that the subject device can maintain skin temperature at least 10 minutes in one treatment time (15 minutes).
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 and 40cm. Set the treatment time at 15 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 25°C. For the predicate device, put an electronic temperature sensor at the distance 12", 15' and 18''. Set the treatment time at 60 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 25℃. The result shows that both devices can achieve the temperature range 41-45°C which is an effective therapy temperature range.
The testing report shows that Infrared Lamp (Model#: FIR 51 and SN-51) is as effective as predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
Submitter's Information 1.0
Establishment Registration Name:
MAR 3 0 2011
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
Device Information 2.0
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Infrared Lamp |
| Trade Name: | Infrared Lamp |
| Model: | |
| Classification name: | FIR 51, SN-51 |
| lamp, infrared, therapeutic heating | |
| Review Panel: | Physical Medicine |
| Product Code: | ILY |
| Regulation Class: | Class II |
| Regulation Number: | 21CFR 890.5500 |
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3.0 Predicate Device Information
| Sponsor: | Lhasa Medical, Inc |
|---|---|
| Device: | TDP CQ-27 Heat Lamp |
| 510(K) Number: | K003538 |
| Sponsor: | Foshan Gaunying Electronics Co., Ltd. |
| Device: | Infrared Lamp Model FIR 51, SN-51 |
| 510(K) Number: | K102149 |
4.0 Device description
Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is a non-invasive, portable infrared lamp designed to deliver light energy in the infrared spectrum to the target tissue. The light energy is emitted by a built-in Halogen lamp. rated 110-130 Vac. which is enclosed by plastic enclosure, except front panel which is a ceramic / glass plating.
Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display.
The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.
5.0 Intended Use
The Infrared Lamp is 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 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)). (General)
- UL 60601-1, first edition, 2003, deviations to IEC 60601-1 .
2
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 400 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
- Compare with predicate device Gaunying Infrared Lamp Model FIR 51, SN-51 8.1 (K102149)
The subject device and the predicate device is exactly the same product, except that predicate device is intended for prescription use, while subject device is intended for over-the-counter use.
The difference between subject device and predicate device is in the labeling. The labeling of subject device is readable and understandable for over-the-counter use.
So, the difference 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.
- Compare with predicate device TDP CQ-27 Heat Lamp made by Lhasa Medical, 8.2 Inc (K003538)
Compared with predicate device TDP CO-27 Heat Lamp made by Lhasa Medical, Inc (K003538), 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 2 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.
3
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 and 40cm. Set the treatment time at 15 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 25°C. For the predicate device, put an electronic temperature sensor at the distance 12", 15' and 18''. Set the treatment time at 60 minutes, and then record the temperature at the end of setting time. The test ambient temperature condition: 25℃. The result shows that both devices can achieve the temperature range 41-45°C which is an effective therapy temperature range.
The testing report shows that Infrared Lamp (Model#: FIR 51 and SN-51) is as effective as predicate device.
The subject device and predicate device also have difference in shape, rated power, cooling means, timing controller and installation. However, analyses and testing show that the difference does not raise new questions of safety and effectiveness. The new device passes the safety testing, and the risk management report shows all the risks are under control.
As identical predicates of these devices have been in safe and effective applications by layperson users. Over-The-Counter variance is requested.
So, the difference 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
9.0 Submission date: Dec 20, 2010
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.
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
MAR 3 0 201
Re: K110721
Trade/Device Name: Gaunying Infrared Lamp (Model # FIR 51. SN-51) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 14, 2011 Received: March 15, 2011
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.
Sincerely yours,
Al. B. Rh
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Indications for Use
510(k) Number (if known):
Device Name: Infrared Lamp Model: FIR 51, SN-51
Indications For Use:
The infrared lamp is 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
signature
Page 1 of l
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11072/
Section 4, Page 1 of 1