(262 days)
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.
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.
This document pertains to a 510(k) premarket notification for a medical device (WSTM Far-Infrared Therapy Unit, Model: KP-B210) and does not describe a study involving an algorithm's performance, human readers, or ground truth establishment in the context of AI. Therefore, I cannot extract the requested information.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (electrical safety, EMC, spectrum, functional certification, usability, and temperature safety tests) and comparing technical specifications. No clinical test data was used to support the decision of substantial equivalence, and there is no mention of an algorithm or AI.
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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
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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
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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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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 TECHNOLOGYCO., LTD. |
| Regulation number: | 890.5500 |
| Device Class: | II |
| Product Code: | ILY |
| 510(k) Number: | K080465 |
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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
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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 deviceK160849 | Predicate deviceK080465 | Rationale | |
|---|---|---|---|---|
| Proprietary name | WSTM Far-InfraredTherapy Unit Model | WSTM Therapy Unit | N/A | |
| Model No. | KP-B210 | TY-101N | TY-101F | N/A |
| Indications for Use | The WSTM Far-Infrared TherapyUnit, Model:KP-B210, may beused for thetemporary relief ofminor muscle andjoint pain andstiffness, thetemporary relief ofminor joint painassociated witharthritis, the | The WSTM therapy units,ty-101n and ty-101f maybe used for the temporaryrelief of minor muscleand joint pain andstiffness, the temporaryrelief of minor joint painassociated with arthritis,the temporar increase inlocal circulation whereapplied and relaxation ofmuscles. In addition, thelamp may also help | IFU of subject deviceis within the scope ofthe predicate device | |
| temporary increase inlocal circulationwhere applied, andrelaxation of muscles.In addition, the lampmay also help musclespasms, minor sprainsand strains. | muscle spasms, minorsprains, and strains, andminor muscular back pain | |||
| Principle of Operation | Far Infrared (FIR)radiation plateincluded in theproposed device iscomposed of delicateceramic plate ( $Al_2O_3$ ),heating element(Electronic pastes),FIR emitting material(Dielectric pastes)and silver electrode(conductor pastes),and can emit energyin the infraredspectrum (3~25 µm). | FIR emitting component,composed of delicateceramic plate, heatingelement, and high IRemissivity mineralmixture (such as silicon,calcium, chromium,copper, carbon etc.) toemit energy inthe infrared spectrum(3~25 µm) | Different but does notadversely impactsafety andeffectiveness ofsubject device | |
| Key component | Far Infrared (FIR)radiation plateincluded in theproposed device iscomposed of delicateceramic plate ( $Al_2O_3$ ),heating element(Electronic pastes),FIR emitting material(Dielectric pastes)and silver electrode(conductor pastes) | FIR emitting componentcomposed ofdelicate ceramic plate,heating element,and high IR emissivitymineral mixture. | Different but does notadversely impactsafety andeffectiveness ofsubject device | |
| Location | Forearm | Entire body | Different but does notadversely impactsafety andeffectiveness ofsubject 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 notadversely impactsafety andeffectiveness ofsubject device | |
| Enclosure Leakagecurrent | <0.05 mA | <0.05 mA | Same | |
| Fuse | 1A | 2A | Different but does notadversely impactsafety andeffectiveness ofsubject device | |
| Spectrum range | 3-25 um | 3-25 um | Same | |
| Emitting Area | 50mm x 100mm x 2 pcs | 50mm x 100mm x 4 pcs | Similar | |
| Treatment Area | ~100 cm² | ~200 cm² | Different but does notadversely impactsafety andeffectiveness ofsubject device | |
| Distance of radiation | 15-30 cm | 15-30 cm | Same | |
| Power density ofirradiated area | 10-20 mW/cm² | 20-30 mW/cm² | Different but does notadversely impactsafety andeffectiveness ofsubject device | |
| Power consumption | <100 watts | <200 watts | Different but does notadversely impactsafety andeffectiveness ofsubject device | |
| Temperature at heatingsurface | High 230 ± 15°CLow 180 ± 10°C | High 230 ± 15°CMedium 200 ± 15°CLow 180 ± 10°C | Similar | |
| Recommended Time ofradiation | 20-40 mins | 20-40 mins | Same | |
| Storage environment | Temp: -15°C – 50°CRH: 10% - 90% | Temp: -15°C – 70°CRH: 10% - 90% | Same | |
| Shipping environment | Temp: -15°C – 70°CRH: 10% - 90% | Temp: -15°C – 70°CRH: 10% - 90% | Same | |
| Operation environment | Temp: 10°C – 30°CRH: 10% - 90% | Temp: 10°C – 40°CRH: 10% - 90% | Similar | |
| Emitter Use Life | 3000 hours | 1000 – 1500 hours | Does not adverselyimpact safety andeffectiveness ofsubject device | |
| Product Shelf Life | 5 years | 3 years | Does not adverselyimpact safety andeffectiveness ofsubject device | |
| Size | Length: 28 cmWidth: 20 cmHeight: 33.5 cm | Emitter:30 x 25 x12 cmSupporting arm:75 x 15 x 4 cmControl Box:26 x 25 x 20 cmBase: 60 cm diameter | Does not adverselyimpact safety andeffectiveness ofsubject device | |
| Weight | 2.8 Kg/Set | 13.3 Kg/set | 14.0 Kg/setDoes not adverselyimpact safety andeffectiveness of | |
| subject device | ||||
| Cooling fan | Emitter with heatdissipating fan andtemperature controlsensor switch | N/A | Emitterwith heatdissipatingfan andtemperaturecontrolsensorswitch | Same |
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Similarity and differences
The differences between the subject device and the predicate device are configuration and several technical parameters. The subject device has undergone safety and performance tests, and the results complied with the test requests. A comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. Therefore, the difference between the subject device and the predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in intended use, safety and performance claims.
Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that WSTM Far-Infrared Therapy Unit, Model: KP-B210 is substantially equivalent to the predicate device.
N/A