(262 days)
Not Found
No
The summary describes a simple infrared heating device with basic controls and safety features. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
Yes
The device is described as a "non-invasive physiology therapy device" intended for "therapeutic applications" for temporary relief of various muscle and joint pain conditions, which aligns with the definition of a therapeutic device.
No
The device is described as an infrared heating system for therapeutic applications (e.g., pain relief, circulation increase, muscle relaxation), not for diagnosing medical conditions.
No
The device description clearly states it is an "infrared heating system" with physical components like an emitter, control panel, power switch, and safety distance reminder. It is a hardware device that emits far-infrared energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for providing temporary relief of pain, stiffness, and muscle issues through the application of far-infrared heat. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as an infrared heating system that emits topical heat. This aligns with a physical therapy or pain relief device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) or to provide information about a disease or condition based on such examination.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide diagnostic information. This device operates in vivo (on the body) to provide therapeutic relief.
N/A
Intended Use / Indications for Use
The WS(TM) Far-Infrared Therapy Unit, Model: KP-B210, 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.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The WSTM Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 um Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human forearm and upper arm
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)
Non-clinical Testing:
A series of safety and performance tests were performed on the proposed device, WSTM Far-Infrared Therapy Unit, Model: KP-B210.
- Electrical safety and EMC tests
- Spectrum test
- Function certification test .
- Functional characteristics of the user panel
- Operational characteristics of the emitter
- Tip-over safety protection
- Usability test
- Temperature safety tests
Key results: The spectrum test demonstrates that the proposed device can emit far-infrared and the wavelength is 3 to 25 um as intended. And the function certification test demonstrates that the proposed device can meet the functional and operational requirements and its intended use. Temperature safety testing shows that the device would not cause any skin burns, safety concerns or fire risks. The comparison analysis has also been conducted to prove the substantial equivalence between the proposed and predicate device.
Clinical Testing: No clinical test data was used to support the decision of substantial equivalence.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
WS Far IR Medical Technology Co., Ltd. Chih-wen Tsai Product Specialist 2f, No.4, Lane 130, Minquan Rd. Xindian Dist. New Taipei City, 231 TW
Re: K160849
Trade/Device Name: WSTM Far-infrared Therapy Unit, Model: KP-B210 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: November 1, 2016 Received: November 14, 2016
Dear Chih-wen Tsai:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 yours.
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) K160849
Device Name
WS(TM) Far-Infrared Therapy Unit, Model KP-B210
Indications for Use (Describe)
The WS(TM) Far-Infrared Therapy Unit, Model: KP-B210, 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.
| 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
510(k) Summary K160849
| Type of Submission: | Traditional |
|---|---|
| Date of Summary: | November 1, 2016 |
| Submitter: | WS FAR IR MEDICAL TECHNOLOGY CO., LTD |
| Address: | 2F., No.4, Lane 130, Minquan Rd., Xindian |
| Dist., New Taipei City 231, Taiwan (R.O.C.) | |
| Phone: | +886-2-8219-2005 |
| Fax: | +886-2-8219-2009 |
| Contact: | CHIH-WEN TSAI (info@far-infrared.com.tw) |
Identification of the Device:
| Identification of the Device: | |
|---|---|
| Proprietary/Trade name: | WSTM Far-Infrared Therapy Unit, |
| Model: KP-B210 | |
| Regulation Description: | Infrared lamp |
| Review Panel: | Physical Medicine |
| Regulation Number: | 890.5500 |
| Device Class: | II |
| Product Code: | ILY |
Identification of the Predicate Device:
| Predicate Device Name: | WSTM Far-Infrared Therapy Unit,
Model # TY-101 Series |
|------------------------|----------------------------------------------------------|
| Manufacturer: | WS FAR IR MEDICAL TECHNOLOGY
CO., LTD. |
| Regulation number: | 890.5500 |
| Device Class: | II |
| Product Code: | ILY |
| 510(k) Number: | K080465 |
4
Intended Use/ Indications for Use of the subject device
The WSTM Far-Infrared Therapy Unit, Model: KP-B210, 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.
Device Description
The WSTM Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 um Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
Non-clinical Testing
A series of safety and performance tests were performed on the proposed device, WSTM Far-Infrared Therapy Unit, Model: KP-B210.
- . Electrical safety and EMC tests
- . Spectrum test
- Function certification test .
- Functional characteristics of the user panel
- Operational characteristics of the emitter -
- Tip-over safety protection
- . Usability test
- . Temperature safety tests
The spectrum test demonstrates that the proposed device can emit far-infrared and the wavelength is 3 to 25 um as intended. And the function certification test demonstrates that the proposed device can meet the functional and operational requirements and its intended use. Temperature safety testing shows that the device
5
would not cause any skin burns, safety concerns or fire risks. The comparison analysis has also been conducted to prove the substantial equivalence between the proposed and predicate device.
Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
Substantial Equivalence Determination
The WS™ Far-Infrared Therapy Unit, Model: KP-B210 has the same intended use, same principle of operation and similar technological characteristics with the predicate device (K080465). A series of tests were performed and demonstrated substantial equivalence between the proposed and the predicate device. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.
| Item | Subject device
K160849 | Predicate device
K080465 | | Rationale |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Proprietary name | WSTM Far-Infrared
Therapy Unit Model | WSTM Therapy Unit | | N/A |
| Model No. | KP-B210 | TY-101N | TY-101F | N/A |
| Indications for Use | The WSTM Far-Infrared Therapy
Unit, Model:
KP-B210, 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 | The WSTM therapy units,
ty-101n and ty-101f 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 temporar increase in
local circulation where
applied and relaxation of
muscles. In addition, the
lamp may also help | | IFU of subject device
is within the scope of
the predicate device |
| | temporary increase in
local circulation
where applied, and
relaxation of muscles.
In addition, the lamp
may also help muscle
spasms, minor sprains
and strains. | muscle spasms, minor
sprains, and strains, and
minor muscular back pain | | |
| Principle of Operation | Far Infrared (FIR)
radiation plate
included in the
proposed device is
composed of delicate
ceramic plate ( $Al_2O_3$ ),
heating element
(Electronic pastes),
FIR emitting material
(Dielectric pastes)
and silver electrode
(conductor pastes),
and can emit energy
in the infrared
spectrum (325 µm). | FIR emitting component,25 µm) | Different but does not
composed of delicate
ceramic plate, heating
element, and high IR
emissivity mineral
mixture (such as silicon,
calcium, chromium,
copper, carbon etc.) to
emit energy in
the infrared spectrum
(3
adversely impact
safety and
effectiveness of
subject device | |
| Key component | Far Infrared (FIR)
radiation plate
included in the
proposed device is
composed of delicate
ceramic plate ( $Al_2O_3$ ),
heating element
(Electronic pastes),
FIR emitting material
(Dielectric pastes)
and silver electrode
(conductor pastes) | FIR emitting component
composed of
delicate ceramic plate,
heating element,
and high IR emissivity
mineral mixture. | Different but does not
adversely impact
safety and
effectiveness of
subject device | |
| Location | Forearm | Entire body | Different but does not
adversely impact
safety and
effectiveness of
subject device | |
| Power setting | High, Low | High, Medium, Low | Similar | |
| Time setting | 10-90 minutes | 0-90 minutes auto timer | Similar | |
| Input power/Frequency | 110V, 50/60Hz | 110V, 50/60Hz | Same | |
| Rated current | 0.7A | 1.4A | Different but does not
adversely impact
safety and
effectiveness of
subject device | |
| Enclosure Leakage
current |