(151 days)
Not Found
No
The device description and intended use focus on providing topical heat using a ceramic plate and infrared emission. There is no mention of AI, ML, image processing, or data-driven decision-making. The performance studies focus on verifying output parameters and substantial equivalence to predicate devices, not on evaluating AI/ML performance metrics.
Yes
The device is intended for the temporary relief of pain and stiffness, relaxation of muscles, and related therapeutic effects, which are medical benefits.
No
The device description and intended use indicate that the Bashan TDP Heat Lamp is for therapeutic purposes (pain relief, circulation, muscle relaxation) by providing topical heat, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a ceramic plate, power specifications (110 volt, 250 watts), timer, and safety fuses, indicating it is a physical device, not software-only.
Based on the provided information, the Bashan TDP Heat Lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the temporary relief of muscle and joint pain, stiffness, and other physical ailments. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a heat lamp that provides topical heating to the body. This aligns with a physical therapy or pain relief device, not a device used to examine specimens from the human body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Bashan TDP Heat Lamp does not fit this description.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
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.
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)
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and connection. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
| 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: +86-23-65462778 Fax: +86-23-65462778 Email: 191513131@qq.com
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: +86-20-61099984 Email: regulatory@glomed-info.com
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
4
| 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;
5
| 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
| Comparison | Subject Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Manufacturer | Chongqing YUHE | |||
| Medical Instruments Co., | ||||
| Ltd. | Prime Herbs | |||
| Corporation | ||||
| Chongqing Xinfeng | ||||
| Medical Instrument | ||||
| Co., Ltd. | -- | |||
| Device Name | Bashan TDP Heat Lamp | |||
| (Models: TDP-124D, | ||||
| TDP-166D, TDP-124F, | ||||
| TDP-166F) | Precision TDP Lamp, | |||
| Precision Heat Lamp, | ||||
| Precision Infrared | ||||
| Lamp, Marvel Lamp, | ||||
| Wonder Lamp | ||||
| Xinfeng Heating Lamp | ||||
| (Models: CQ-27, CQ- |
-
| -- | |
| 510(k) Number | Applying | K081720
K043558 | -- | |
| Product Code | ILY | ILY
ILY | SE | |
| 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 | The Precision TDP
lamp, Precision Heat
Lamp, Precision
Infrared Lamp, Marvel
Lamp and Wonder
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
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. | SE | |
| | | | | |
| | sprains and strains, and
minor muscular back
pain. | 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. | In addition, it may also
help muscle spasms,
minor sprains and
strains, and minor
muscular back pain. | |
| Type of Use | OTC | OTC | Prescription | SE |
| Key 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 | SE |
| Power Input
Rating | 250W maximum, 50/60
Hz | 250W maximum, 50/60
Hz | 250W maximum, 50/60
Hz | SE |
| Spectrum Range | 5 ~ 25 microns | 2 ~ 50 microns | 5 ~ 25 microns | SE |
| Warming Up
Time | 15 minutes | -- | 15 minutes | SE |
| Total Working
Hours | 1000 Hours | 1200 ~ 1500 Hours | 1000 Hours | SE |
| Operating Timer | Up to 60 minutes | -- | Up to 95 minutes | SE
Note 1 |
| Placement Type | Models TDP-124D &
TDP-166D: desktop
type;
Models TDP-124F, TDP-
166F: floor type | -- | Desktop type | SE
Note 2 |
| Radiant Plate
Diameter | TDP-124D & TDP-124F:
12.4 cm;
TDP-166D & TDP-166F:
16.6 cm | -- | 16.6 cm | SE
Note 3 |
| Skin
Temperature | The distance from lamp
head and the testing
result:
(1) Models TDP-124D &
TDP-124F:
20cm distance: 45°C;
25cm distance: 42°C;
30cm distance: 40°C
(2) Models TDP-166D &
TDP-166F:
20cm distance: 45°C;
25cm distance: 43°C;
30cm distance: 41°C | -- | The distance from lamp
head and the testing
result:
8" (20cm) distance:
45°C:
10" (25cm) distance:
43°C;
12" (30cm) distance:
41°C | SE
Note 4 |
| Compliance
Standards | AAMI/ANSI ES 60601-1,
IEC 60601-1-2,
IEC 60601-1-11 | IEC 60601-1,
IEC 60601-1-2 | IEC 60601-1,
IEC 60601-1-2 | SE
Note 5 |
8. Comparison to predicate device and conclusion
6
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
7
| 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 |
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.