Bashan TDP Heat Lamp

K162590 · Chogqing Yuhe Medical Instruments Co., Ltd. · ILY · Feb 14, 2017 · Physical Medicine

Device Facts

• Record ID: K162590
• Device Name: Bashan TDP Heat Lamp
• Applicant: Chogqing Yuhe Medical Instruments Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Feb 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Bashan TDP Heat Lamp is used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

Bashan TDP Heat Lamp provides topical heating to body; utilizes rare earth ceramic plate to emit infrared spectrum (5-25 microns). Device includes heating head, swing arm, control box, and pedestal; operates on 110V power (250W). Intended for OTC use in home healthcare environment; operated by patient. User sets timer (up to 60 minutes) to control duration of heat application. Heat output (40-45°C at 20-30cm distance) promotes local circulation and muscle relaxation, providing temporary relief of pain and stiffness. Safety features include timer and fuses. Compliance with IEC 60601-1-11 ensures safety for home use.

Clinical Evidence

Bench testing only. Performance testing verified output parameters (spectrum 5-25 microns, skin temperature 40-45°C at 20-30cm). Usability study conducted on 500 eligible users demonstrated ability to comprehend labeling and operate device safely as intended.

Technological Characteristics

Rare earth ceramic plate emitter; 5-25 micron infrared spectrum; 110V/250W power; desktop or floor-standing form factor; includes timer and safety fuses. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11.

Indications for Use

Indicated for patients requiring temporary relief of minor muscle/joint pain, stiffness, arthritis-related joint pain, muscle spasms, minor sprains/strains, and minor muscular back pain; also for increasing local circulation and muscle relaxation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Precision TDP Lamp, Precision Infrared Lamp, Marvel Lamp, Wonder Lamp (K081720)
• Xinfeng Lamp (K043558)

Submission Summary (Full Text)

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

February 14, 2017

Chogqing Yuhe Medical Instruments Co., Ltd. Liu Yong General Manager No.104-8 City Garden Mid Road, Shapingba District Chongqing, 400038 CN

Re: K162590

Trade/Device Name: Bashan TDP Heat Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: January 2, 2017 Received: January 9, 2017

Dear Liu Yong:

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 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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

# Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K162590

Device Name Bashan TDP Heat Lamp

#### Indications for Use (Describe)

Bashan TDP Heat Lamp is used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

| 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)

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| Sponsor: | Chongqing YUHE Medical Instruments Co., Ltd. |
|-----------------|---------------------------------------------------------------------|
| Subject Device: | Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F |
| File No.: | 510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary |

# Chapter 5. 510(k) Summary

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

# 1. Submitter's Information

Company Name: Chongqing YUHE Medical Instruments Co., Ltd. Establishment registration number: Applying Address: No.104-8 City Garden Mid Road, Shapingba District, Chongqing, China Name of contact person: Liu Yong Title: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

# Application Correspondent:

Contact Person: Ms. Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: [phone] Email: [e-mail]

# 2. Subject Device Information:

Type of 510(k) Submission: Traditional Common Name: Infrared lamp Trade Name: Bashan TDP Heat Lamp Models: TDP-124D, TDP-166D, TDP-124F, TDP-166F Classification Name: lamp, infrared, therapeutic heating Review Panel: Physical Medicine Product Code: ILY Regulation Number: 21CFR890.5500 Regulation Class: 2

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| Sponsor: | Chongqing YUHE Medical Instruments Co., Ltd. |
|-----------------|---------------------------------------------------------------------|
| Subject Device: | Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F |
| File No.: | 510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary |

# 3. Predicate Device Information:

# Predicate Device 1:

510(K) Number: K081720 Company Name: Prime Herbs Corporation Trade Name: Precision TDP Lamp, Precision Infrared Lamp, Marvel Lamp, Marvel Lamp, Wonder Lamp Common Name: Infrared Heating Lamp Product Code: ILY

# Predicate Device 2:

510(K) Number: K043558 Company Name: Chongqing Xinfeng Medical Instrument Co., Ltd. Trade Name: Xinfeng Lamp Common Name: Infrared Heating Lamp Product Code: ILY

# 4. Device Description

Bashan TDP Heat Lamp is used to provide topical heating to the body. It is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 5 to 25 microns, 110 volt power, 250 watts. It includes timer, safety fuses.

#### 5. Intended Use / Indications for Use

Bashan TDP Heat Lamp is used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

#### 6. Test Summary

Bashan TDP Heat Lamp is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

- � AAMI/ANSI ES60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance, Edition 2005/(R)2012 and A1:2012;
- � IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, Edition 4.0, 2014;

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| Sponsor: | Chongqing YUHE Medical Instruments Co., Ltd. |
|-----------------|---------------------------------------------------------------------|
| Subject Device: | Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F |
| File No.: | 510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary |

- � IEC 60601-1-11: Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment, Edition 2.0, 2015;
- � The performance test report has also been conducted to verify the output parameters of the device.

The result of tests indicates that the Bashan TDP Heat Lamp is safe and effective, and the substantial equivalent performance as the legally marketed predicate device.

# 7. Usability Study

Usability study was conducted on 500 eligible device users. The study evaluated the users' ability to comprehend the device labeling and operate the device as intended in a safe and effective means. The study results showed that potential device users could successfully operate the device as intended with no safety issues reported.

| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | Chongqing YUHE<br>Medical Instruments Co.,<br>Ltd. | Prime Herbs<br>Corporation<br>Chongqing Xinfeng<br>Medical Instrument<br>Co., Ltd. | -- | |
| Device Name | Bashan TDP Heat Lamp<br>(Models: TDP-124D,<br>TDP-166D, TDP-124F,<br>TDP-166F) | Precision TDP Lamp,<br>Precision Heat Lamp,<br>Precision Infrared<br>Lamp, Marvel Lamp,<br>Wonder Lamp<br>Xinfeng Heating Lamp<br>(Models: CQ-27, CQ-<br>36) | -- | |
| 510(k) Number | Applying | K081720<br>K043558 | -- | |
| Product Code | ILY | ILY<br>ILY | SE | |
| Indications for<br>Use | Bashan TDP Heat Lamp<br>is used for the temporary<br>relief of minor muscle<br>and joint pain and<br>stiffness, the temporary<br>relief of minor joint pain<br>associated with arthritis,<br>the temporary increase<br>in local circulation where<br>applied, and the<br>relaxation of muscles. In<br>addition, it may also help<br>muscle spasms, minor | The Precision TDP<br>lamp, Precision Heat<br>Lamp, Precision<br>Infrared Lamp, Marvel<br>Lamp and Wonder<br>Lamp may be used for<br>the temporary relief of<br>minor muscle and joint<br>pain and stiffness, the<br>temporary relief of<br>minor joint pain<br>associated with<br>arthritis, the temporary<br>Bashan TDP Heat<br>Lamp is used for the<br>temporary relief of<br>minor muscle and joint<br>pain and stiffness, the<br>temporary relief of<br>minor joint pain<br>associated with<br>arthritis, the temporary<br>increase in local<br>circulation where<br>applied, and the<br>relaxation of muscles. | SE | |
| | | | | |
| | sprains and strains, and<br>minor muscular back<br>pain. | increase in local<br>circulation where<br>applied, and the<br>relaxation of muscles.<br>In addition, it may also<br>help muscle spasms,<br>minor sprains and<br>strains, and minor<br>muscular back pain. | In addition, it may also<br>help muscle spasms,<br>minor sprains and<br>strains, and minor<br>muscular back pain. | |
| Type of Use | OTC | OTC | Prescription | SE |
| Key Components | Heating head<br>Swing arm<br>Control box<br>Pedestal with extension | Heating head<br>Swing arm<br>Control box<br>Pedestal with<br>extension | Heating head<br>Swing arm<br>Control box<br>Pedestal with<br>extension | SE |
| Power Input<br>Rating | 250W maximum, 50/60<br>Hz | 250W maximum, 50/60<br>Hz | 250W maximum, 50/60<br>Hz | SE |
| Spectrum Range | 5 ~ 25 microns | 2 ~ 50 microns | 5 ~ 25 microns | SE |
| Warming Up<br>Time | 15 minutes | -- | 15 minutes | SE |
| Total Working<br>Hours | 1000 Hours | 1200 ~ 1500 Hours | 1000 Hours | SE |
| Operating Timer | Up to 60 minutes | -- | Up to 95 minutes | SE<br>Note 1 |
| Placement Type | Models TDP-124D &<br>TDP-166D: desktop<br>type;<br>Models TDP-124F, TDP-<br>166F: floor type | -- | Desktop type | SE<br>Note 2 |
| Radiant Plate<br>Diameter | TDP-124D & TDP-124F:<br>12.4 cm;<br>TDP-166D & TDP-166F:<br>16.6 cm | -- | 16.6 cm | SE<br>Note 3 |
| Skin<br>Temperature | The distance from lamp<br>head and the testing<br>result:<br>(1) Models TDP-124D &<br>TDP-124F:<br>20cm distance: 45°C;<br>25cm distance: 42°C;<br>30cm distance: 40°C<br>(2) Models TDP-166D &<br>TDP-166F:<br>20cm distance: 45°C;<br>25cm distance: 43°C;<br>30cm distance: 41°C | -- | The distance from lamp<br>head and the testing<br>result:<br>8" (20cm) distance:<br>45°C:<br>10" (25cm) distance:<br>43°C;<br>12" (30cm) distance:<br>41°C | SE<br>Note 4 |
| Compliance<br>Standards | AAMI/ANSI ES 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-11 | IEC 60601-1,<br>IEC 60601-1-2 | IEC 60601-1,<br>IEC 60601-1-2 | SE<br>Note 5 |

# 8. Comparison to predicate device and conclusion

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Sponsor:

Subject Device:

Chongqing YUHE Medical Instruments Co., Ltd. Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-166F

File No.:

510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary

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| Sponsor: | Chongqing YUHE Medical Instruments Co., Ltd. |
|-----------------|-------------------------------------------------------------------------|
| Subject Device: | Bashan TDP Heat Lamp, Models: TDP-124D, DP-166D, TDP-124F, TDP-<br>166F |
| File No.: | 510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary |

#### Comparison in Detail

# Note 1 - 3:

The Operating Timer, Placement Type, Inner Cover Diameter of subject devices are a little difference from predicate devices. They are both compliance with IEC 60601-1 requirements. So the difference will not raise any safety or effectiveness issue.

# Note 4:

The Skin Temperature of subject devices are a little difference from predicate devices, but the effective skin temperatures are between 40 ~ 45 ℃ in 8" ~ 12" distance from lamp head. So the difference will not raise any safety or effectiveness issue.

# Note 5:

The Compliance Standards of subject devices are a little difference from predicate devices, but the subject devices are also complied with home healthcare environment used device standard IEC 60601-1-11 for OTC used. So the difference will not raise any safety or effectiveness issue.

# Finial conclusion:

The subject device Bashan TDP Heat Lamp (Models: TDP-124D, TDP-166D, TDP-124F, TDP-166F) has all features of predicate devices, the Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp, Wonder Lamp (K081720) and Xinfeng Heating Lamp (K043558). The differences between them do not affect the safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate devices.

# 9. Date of the summary prepared: February 9, 2017