The subject device may be 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 relaxation of muscles. In addition, the device may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

QK Therapeutic Apparatus, including 7 different models, consists of Energy generator, Height adjustment knob, Support, and Control box. It is used to provide topical heating to the body by the energy generator. The energy generator is composed of many semiconductor ceramic piece, and it can emit multiple peak wide-band nanometer waves which can be absorbed by human.

The device C01A, C01B, C01CZ, C01EZ and QK-S14 are desktop style, while the other models are Floor Standing. The Emission spectrum ranges from 6K to 12K nm, the Energy Peak Value Wave Range is 9300nm±465nm and the All-direction Eradiation Rate is at least 83 %, The energy generator shall be replaced after 15000 hours of usage.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "QK Therapeutic Apparatus." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria. Therefore, much of the requested information regarding a device performance study is not available in this document.

Here's the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in the context of a clinical performance study. Instead, it compares the subject device's technical specifications and intended use against a predicate device to demonstrate substantial equivalence. The "performance" reported primarily relates to physical and electrical characteristics and adherence to safety standards.

Characteristic / Acceptance Criteria (Implied for Substantial Equivalence Comparison)	Reported Device Performance (QK Therapeutic Apparatus)
Indications for Use	Temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, relaxation of muscles. May also help muscle spasms, minor sprains & strains, and minor muscular back pain.
Operation Principle	Energy generator emits infrared wave to provide topical heating for the purpose of temporary pain relief of muscular pain, arthritis, shoulder pain, back pain and joint stiffness.
Spectrum Ranges	6K~12Knm
Peak Wave Length	9300±465nm
Length of Generator	18.5~35.5cm
Lifetime of Generator	15000h
Control Timer	No or Yes
Power Supply	AC120V
Power	160~230W
Power Frequency	50~60Hz
Warm-Up Time	3 min
Irradiation Distance	20-30cm
Irradiation Time	High: 20-40min/turn, Low: 30-60min/turn
Maintain Time	15-20min
Skin Temperature	40-45°C
Style	Desktop & Floor standing
Operating Environment	Temperature: 5℃~40℃, Humidity: ≤85%RH
Storage Environment	Temperature: -40°C ~55°C, Humidity : ≤85%RH
Conformance Standard	IEC60601-1 (Safety), IEC60601-1-2 (EMC)

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

Sample size for the test set: Not applicable. The document does not describe a clinical performance study with a test set of patient data. The "performance data" refers to compliance with electrical safety and EMC standards and "performance test result in section 11 of this submission" (which is not included in the provided text, but likely refers to technical specifications rather than patient outcomes).
Data provenance: Not applicable for a clinical test set. The technical specifications and compliance data would originate from the manufacturer's internal testing and laboratories. The country of origin of the device manufacturer is China.

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

Not applicable. No clinical ground truth or expert-reviewed test set is described in this document.

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

Not applicable. No clinical test set or adjudication process is described.

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 therapeutic apparatus, not an AI-assisted diagnostic or interpretative device that would involve human readers.

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

Not applicable. This is not an algorithm-based device. Its performance is demonstrated through technical specifications and compliance with safety standards.

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

Not applicable for a clinical performance study. The "ground truth" for demonstrating substantial equivalence relies on comparing the device's technical specifications and safety/EMC compliance to a legally marketed predicate device and recognized standards (IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not a machine learning/AI device.

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

Not applicable. There is no mention of a training set.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

January 28, 2015

Harbin Quanke Medi-Technical Development Co., Ltd. Xianglin Wang CEO No.42-1 Lane2 JingWei Str. Daoli Dist. Harbin, Heilongjiang, China 150010

Re: K141892

Trade/Device Name: QK-Therapeutic Apparatus; Models QK-C01A, QK-C01B, QK-C01CZ, QK-C01EZ, QK-S14, QK-C02FZ, QK-C02D Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: December 10, 2014 Received: December 29, 2014

Dear Xianglin 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. 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.

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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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Felipe Aquel -S

for Carlos Peña, Ph.D., M.S. 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) K141892

Device Name

QK Therapeutic Apparatus; Models QK-C01A, QK-C01CZ, QK-C01EZ, QK-S14, QK-C02FZ, and QK-C02D

Indications for Use (Describe)

The subject device may be used for the temporary relief of min and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the device may also help muscle spasms, minor sprains and minor muscular back pain.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows two logos. The first logo features a stylized letter "R" with a teal arc above it, accompanied by the registered trademark symbol. The second logo consists of red stylized letters "QK" enclosed in a red square frame, with Chinese characters below it. The logos appear to represent two different brands or organizations.

Section 5 510(K) Summary

1. Prepared date: 2015-1-23

2. Submitter Information

Name	Harbin Quanke Medi-Technical Development Co.,Ltd.
Address	No.42-1 Lane2 JingWei Str .Daoli Dist. Harbin,Heilongjiang,
	China, 150010
Tel	+86 451-84674063
Fax	+86 451-84671775
Contact person	Wang xianglin
E-mail	qkgs@vip.163.com

3. Device Information

Trade name	QK Therapeutic Apparatus
Model	QK-C01A, QK-C01B, QK-C01CZ, QK-C01EZ, QK-S14, QK-C02FZ, QK-C02D
Common name	Infrared therapeutic heating lamp
Classification name	lamp, infrared, therapeutic heating
Regulatory class	Class 2
Production regulation	21CFR Part 890.5500
Product code	ILY
Panel	Physical Medicine

4. Predicate Device

Submitter	C&H International Inc
Manufacturer	Chongqing Silicate Research Institute
Trade name	TDP Heat Lamps
Model	CQG-111A/B,CQG-222A/B/D,CQG-270A/B
Product code	ILY
510(K)	K020851

5. Device Description

QK Therapeutic Apparatus, including 7 different models, consists of Energy generator,Height adjustment knob,Support ,and Control box. It is used to provide topical heating to the body by the energy generator.The energy generator is composed of many semiconductor ceramic piece, and it can emit multiple peak wide-band nanometer waves which can be absorbed by human.

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Harbin Quanke Medi-Technical Development Co.,Ltd.

Eradiation Rate is at least 83 %,The energy generator shall be replaced after 15000 hours of usage.

6. Indications for Use

7. Summary of Substantially Equivalent

The subject device and the predicate device have the same intended use, operation principle and Conformance standard, and have the similar technical data, see the Table 1

Compareditem	Subject DevicePresent application	Predicate DeviceK020851	Comment
Indicationsfor use	The subject device may beused for the temporary reliefof minor muscle and jointpain and stiffness, thetemporary relief of minorjoint pain associated witharthritis, the temporaryincrease in local circulationwhere applied, andrelaxation of muscles. Inaddition, the device may alsohelp muscle spasms, minorsprains and strains, andminor muscular back pain.	The TDP Heat Lamp maybe used for the temporaryrelief of minor muscle andjoint pain and stiffness,the temporary relief ofminor joint painassociated with arthritis,the temporary increase inlocal circulation whereapplied, and relaxation ofmuscles. In addition, thelamp may also helpmuscle spasms, minorsprains and strains, andminor muscular back pain.	Same
Operationprinciple	The device's energygenerator can emit infraredwave to provide topicalheating for the purpose oftemporary pain relief ofmuscular pain, arthritis,shoulder pain, back pain andjoint stiffness.	The mineral curing plateof the TDP heat lamp canemit a infrared wave toprovide topical heating forthe purpose oftemporary pain relief ofmuscular pain, arthritis,shoulder pain, back painand joint stiffness	Same
Spectrum	6K~12Knm	2K~25Knm	Similar
Ranges
Peak wavelength	9300±465nm	10000±1000 nm	Similar
Length ofgenerator	18.5~35.5cm	16.6-12.4cm	Similar
Lifetime ofgenerator	15000h	1000~1500h	Similar
ControlTimer	No or Yes	Yes	Similar
PowerSupply	AC120V	220~240V	Similar
Power	160~230W	120~300W	Similar
PowerFrequency	50~60Hz	50~60Hz	Same
Warm-UpTime	3 min	10min	Similar
Irradiationdistance	20-30cm	30-40cm	Similar
Irradiationtime	High: 20-40min/turnLow:30-60min/turn	15-60min/turn	Similar
Maintaintime	15-20min	15-20min	Similar
SkinTemperature	40-45°C	40-45°C	Same
Style	Desktop&Floor standing	Desktop&Floor standing	Same
OperatingEnvironment	Temperature: 5℃~40℃Humidity: ≤85%RH	Temperature: 10°C ~ 40°CHumidity: 10%~ 95% RH	Similar
StorageEnvironment	Temperature: -40°C ~55°CHumidity : ≤85%RH	Temperature: 10°C ~40°CHumidity: 10% ~ 95% RH	Similar
Conformancestandard	IEC60601-1(Safety),IEC60601-1-2(EMC)	IEC60601-1(Safety),IEC60601-1-2(EMC)	Same

Table 1

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Harbin Quanke Medi-Technical Development Co.,Ltd.

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Harbin Quanke Medi-Technical Development Co.,Ltd.

From the comparison form above, the subject device and predicate device have the same Indications for use, Operation principle, Power Frequency, skin temperature , maintain time, Style and Conformance standard.

In the Spectrum Range, length of generator lifetime, Warm-up time, Irradiation distance, Irradiation time items, the subject device is slightly different from the predicate device, but the subject meets the requirements of IEC60601-1, IEC60601-1-2 and performance, so these difference does not bring any problem of effectiveness and safety.

8. Performance Data

8.1 The subject device has tested and complied with the following voluntary recognized standards:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for . Safety, 1988+A1:1991+A2:1995
- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements . for Safety -Collateral Standard: Electromagnetic Compatibility-Requirements and Tests, 2007.
8.2 According to the performance test result in section 11of this submission ,the irradiation distance is 20-30cm, the irradiation time is 30-60min/turn, and the skin Temperature is 40-45°C.

9. Conclusion

The QK Therapeutic Apparatus is substantially equivalent to the predicate devices in K020851.

Regulation Number and Section

N/A