HUANQIU Heating lamp, including CQ-27, CQ-29 and CQ-67, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

The device consists of heating head, swing arm, control box and pedestal with extension. It is used to provide topical heating to the body and is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,000 to 1500 hours of usage. 110 volt power, 250 watts. There are two different types of control: standard control and digital display control.

AI/ML Overview

The HUANQIU Heating Lamp (models CQ-27, CQ-29, and CQ-67) is an infrared lamp device. The study to prove the device meets acceptance criteria is a substantial equivalence comparison to the predicate device, the TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. This type of submission (510(k)) does not typically involve clinical trials in the way a pharmaceutical might, but instead focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HUANQIU Heating Lamps are based on demonstrating substantial equivalence to the predicate device in terms of components, power, spectrum ranges, warming up time, total working hours, operating timer, number of fuses, inner cover diameter/width, number of casters, and skin temperature at specific distances.

Item	Acceptance Criteria (Predicate: TDP CQ-27 Heat Lamp)	Reported Device Performance (HUANQIU Heating Lamp CQ-27)	Reported Device Performance (HUANQIU Heating Lamp CQ-29)	Reported Device Performance (HUANQIU Heating Lamp CQ-67)
Components	Heating head, swing arm, control box, pedestal with extension	Heating head, swing arm, control box, pedestal with extension	Heating head, swing arm, control box, pedestal with extension	Heating head, swing arm, control box with digital display, pedestal with extension
Power Frequency	50/60 Hz	50/60 Hz	50/60 Hz	50/60 Hz
Power	$\leq 250 W$	$\leq 250 W$	$< 250 W$	$< 250 W$
Spectrum Ranges	2 to 50 microns	2 to 50 microns	2 to 50 microns	2 to 50 microns
Warming Up Time	15 minutes	15 minutes	15 minutes	15 minutes
Total Working Hours	1,200 to 1500 hours	1,000 to 1500 hours	1,000 to 1500 hours	1,000 to 1500 hours
Operating Timer	Up to 60 minutes	Up to 60 minutes	Up to 60 minutes	Up to 60 minutes
Number of Fuse	2	2	2	2
Inner Cover Diameter	12 cm	12 cm	20 cm	30 cm (width implied by "Inner Cover Diameter/width")
Number of Casters	4	4	4	5
Skin Temperature	8" at 45°C, 10" at 43°C, 12" at 41°C (for predicate)	8" at 45°C	8" at 45°C	8" at 46°C, 10" at 42°C, 12" at 40°C (different order presented for new device)
		10" at 43°C	10" at 43°C
		12" at 41°C	12" at 41°C

Note for Skin Temperature: The skin temperature results for the new device are presented in a slightly different order and combination across the tables for each model. For CQ-67, the temperatures at 10" and 12" are slightly different from the predicate at identical distances, but still within a very similar range. This is considered acceptable for substantial equivalence, as minor variations are expected.

2. Sample size used for the test set and the data provenance

The document indicates a substantial equivalence study was performed. For this type of submission, a "test set" in the sense of a clinical trial with a defined sample size of patients is generally not applicable, as the equivalence is primarily demonstrated through technical specifications and adherence to standards.

The data provenance is from the manufacturer's internal testing according to GB 9706.1-1995 (which is identical to IEC 60601-1). This is a retrospective comparison against the known specifications of the predicate device. The country of origin for the manufacturing and potentially the testing is implicitly China, given the device name "HUANQIU" and the location of the applicant and correspondent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a substantial equivalence claim based on technical specifications and international standards (IEC 60601-1), "ground truth" is established through engineering and performance testing rather than expert clinical consensus. The standards themselves are developed by expert committees, but this is not the type of "expert ground truth" typically associated with diagnostic AI studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is a technical specification comparison, not a clinical study requiring adjudication of findings.

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

Not applicable. This device is an infrared heating lamp, not a diagnostic imaging device utilizing AI.

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

Not applicable. This is a physical medical device, not an algorithm. Device performance is assessed based on its physical characteristics and output (e.g., heat, spectrum).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this substantial equivalence study is the technical specifications and performance characteristics of the legally marketed predicate device (TDP CQ-27 Heat Lamp), as well as adherence to recognized international safety and performance standards (GB 9706.1-1995 / IEC 60601-1). The new device is shown to have comparable (substantially equivalent) specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/2 description: The image shows the text "Crosslinks International, Inc." in a serif font. The text is arranged in two lines, with "Crosslinks" on the first line and "International, Inc." on the second line. The text is black and the background is white. The image appears to be a logo or heading from a document.

510 (k) Premarket Notification Summaries

Submission Correspondent

George Su, Ph.D. Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA

Tel: 310-229-5748 Fax: 310-388-1067 Email: crosslinks2000/a aol.com

Applicant:

A & A MEDICAL SUPPLIES INC 5288 valley blvd #1 Los Angeles, CA 90032

Tel: 323-223-6318

Sponsor of the 510(k) Submission:

Same as above.

Device Name:

Proprietary Name: HUANQIU Heating Lamp Common/Usual Name: Infrared Lamp Device Name: Infrared Lamp Product Code: ILY Classification: Class II

Predicate Device:

TDP CQ-27 Heat Lamp Establishment: LHASA Medical Inc. Regulation Number: 890.5500 Product Code: ILY 510(k) Number: K003538 Registration Number: 1222811 Owner/Operator Number: 9003816

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Crosslinks International, Inc.

Description of the HUANQIU Heating Lamps:

Indications for use

Substantial Equivalence Information

HUANQIU CQ-27, CQ-29 and CQ-67 Heating Lamps are generally equivalent to CQ-27 Heat Lamp (K003538) manufactured by Lhasa Medical, Inc. on label and labeling, materials used, specifications and intended use. All the technical data are tested according to GB 9706.1-1995 which is identical to IEC 60601-1

The equivalence information is focused on intended use, materials and specifications. HUANQIU Heating lamps are powered by 110V AC, They have 4 or 5 casters and 2 fuses. The working life of the heating plate is 1000 to 1500 hours. The skin temperature of the treatment area is at 40~45℃ when treating distances are from 8" to 12" from heating unit to treatment surface.

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Crosslinks
International, Inc.

Table 1.

Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	The new device: HUANQIU Heating Lamp CQ-27
	and and and the commend the production of the first of the first of the first of the first of the first of the may

Item	The predicate device	The new device
Components	heating head, swing arm, control box and pedestal with extension	heating head, swing arm, control box and pedestal with extension
Power Frequency	50/60 Hz	50/60 Hz
Power	$\leq 250 W$	$\leq 250 W$
Spectrum Ranges	2 to 50 microns	2 to 50 microns
Warming Up Time	15 minutes	15 minutes
Total Working Hours	1,200 to 1500 hours	1,000 to 1500 hours
Operating Timer	Up to 60 minutes	Up to 60 minutes
Number of Fuse	2	2
Inner Cover Diameter	12 cm	12 cm
Number of Casters	4	4
Skin Temperature	The distance from the lamp head and the result
	8"45°C	10"43 °C	12"41 °C	8"45°C

Table 2.

Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. The new device: HUANQIU Heating Lamp CQ-29

Item	The predicate device	The new device
Components	heating head, swing arm, control box and pedestal with extension	heating head, swing arm, control box and pedestal with extension
Power Frequency	50/60 Hz	50/60 Hz
Power	< 250 W	< 250 W
Spectrum Ranges	2 to 50 microns	2 to 50 microns
Warming Up Time	15 minutes	15 minutes
Total Working Hours	1,200 to 1500 hours	1,000 to 1500 hours
Operating Timer	Up to 60 minutes	Up to 60 minutes
Number of Fuse	2	2
Inner Cover Diameter	12 cm	20 cm
Number of Casters	4	4
Skin Temperature	The distance from the lamp head and the result
	8"45°C	10"43°C	12"41°C	8"45°C

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Crosslinks
International, Inc.

Table 3.

Predicate device: TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. The new device: HUANQIU Heating Lamp CQ-67

Item	The predicate device	The new device
Components	heating headswing armstandard control boxpedestal with extension	heating headswing armcontrol box with digital displaypedestal with extension
Power Frequency	50/60 Hz	50/60 Hz
Power	< 250 W	< 250 W
Spectrum Ranges	2 to 50 microns	2 to 50 microns
Warming Up Time	15 minutes	15 minutes
Total Working Hours	1,200 to 1500 hours	1,000 to 1500 hours
Operating Timer	Up to 60 minutes	Up to 60 minutes
Number of Fuse	2	2
Inner Cover Diameter/width	12 cm	30 cm
Number of Casters	4	5
Skin Temperature	The distance from the lamp head and the result
	8"45	10"43°C
	12"41°C	8"46 °C
	10"42°C	12"40°C

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare. The seal is in black and white.

SEP 3 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A & A Medical Supplies Inc. c/o George Su, Ph.D. Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, California 90067

Re: K052063

Trade/Device Name: Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 4, 2005 Received: July 29, 2005

Dear Dr. Su:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - George Su, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milliman

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification 510(k) Report for HUANQIU HEATING LAMP

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use (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)

Mark A. Millkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K052063

Regulation Number and Section

N/A