(198 days)
Not Found
No
The description focuses on the physical components and technical specifications related to heat generation and emission, with no mention of AI or ML capabilities.
Yes.
The device's intended use is for the temporary relief of various types of pain and muscle relaxation, indicating a therapeutic purpose.
No
The device is described as providing "topical heating to the body" for "temporary relief of minor muscle and joint pain and stiffness," and similar therapeutic uses. It does not mention any function for identifying or analyzing medical conditions.
No
The device description explicitly lists hardware components such as an "Energy generator," "Height adjustment knob," "Support," and "Control box," indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the temporary relief of pain, stiffness, and other physical ailments through topical heating. This is a therapeutic use, not a diagnostic one.
- Device Description: The device description details how the device generates and applies heat to the body. It does not mention any components or processes related to analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD-Specific Information: The document does not contain any information typically found in submissions for IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnostic claims or interpretations.
- Performance metrics like sensitivity, specificity, or AUC, which are relevant to diagnostic accuracy.
The device described is a therapeutic device that uses heat for pain relief and muscle relaxation, similar to the predicate device which is a TDP Heat Lamp.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
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.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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.
1
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
2
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 | ||
| 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.
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
4
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
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.
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
| Compared
item | Subject Device
Present application | Predicate Device
K020851 | Comm
ent |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Indications
for use | 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. | The TDP Heat Lamp 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
lamp may also help
muscle spasms, minor
sprains and strains, and
minor muscular back pain. | Same |
| Operation
principle | The device's energy
generator can emit infrared
wave to provide topical
heating for the purpose of
temporary pain relief of
muscular pain, arthritis,
shoulder pain, back pain and
joint stiffness. | The mineral curing plate
of the TDP heat lamp can
emit a infrared wave to
provide topical heating for
the purpose of
temporary pain relief of
muscular pain, arthritis,
shoulder pain, back pain
and joint stiffness | Same |
| Spectrum | 6K12Knm | 2K25Knm | Similar |
| Ranges | | | |
| Peak wave
length | 9300±465nm | 10000±1000 nm | Similar |
| Length of
generator | 18.535.5cm | 16.6-12.4cm | Similar |1500h | Similar |
| Lifetime of
generator | 15000h | 1000
| Control
Timer | No or Yes | Yes | Similar |
| Power
Supply | AC120V | 220240V | Similar |230W | 120
| Power | 160300W | Similar |60Hz | 50~60Hz | Same |
| Power
Frequency | 50
| Warm-Up
Time | 3 min | 10min | Similar |
| Irradiation
distance | 20-30cm | 30-40cm | Similar |
| Irradiation
time | High: 20-40min/turn
Low:30-60min/turn | 15-60min/turn | Similar |
| Maintain
time | 15-20min | 15-20min | Similar |
| Skin
Temperatu
re | 40-45°C | 40-45°C | Same |
| Style | Desktop&Floor standing | Desktop&Floor standing | Same |
| Operating
Environme
nt | Temperature: 5℃40℃ 95% RH | Similar |
Humidity: ≤85%RH | Temperature: 10°C ~ 40°C
Humidity: 10%
| Storage
Environme
nt | Temperature: -40°C ~55°C
Humidity : ≤85%RH | Temperature: 10°C ~40°C
Humidity: 10% ~ 95% RH | Similar |
| Conforman
ce
standard | 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.
6
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.