WS(TM) Far-Infrared Therapy Unit, Model KP-B210

K160849 · Ws Far IR Medical Technology Co., Ltd. · ILY · Dec 15, 2016 · Physical Medicine

Device Facts

• Record ID: K160849
• Device Name: WS(TM) Far-Infrared Therapy Unit, Model KP-B210
• Applicant: Ws Far IR Medical Technology Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

Non-invasive infrared heating system; delivers 3-25 µm far-infrared (FIR) energy via ceramic radiation plate. Input: electrical power; Transformation: heating element/electronic pastes convert energy to FIR radiation. Output: topical heat applied to forearm/upper arm. Used in home/clinic settings; operated by patient. Device includes emitter, user control panel, power switch, safety distance reminder, and tip-over protection. Heat application promotes local circulation, muscle relaxation, and pain relief. Provider/user monitors output via control panel settings (High/Low) and timer (10-90 mins). Benefits include temporary relief of minor musculoskeletal pain and stiffness.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing only: electrical safety, EMC, spectrum analysis (3-25 µm), functional certification, usability, and temperature safety testing.

Technological Characteristics

FIR radiation plate composed of Al2O3 ceramic, electronic heating pastes, dielectric FIR emitting pastes, and silver electrodes. Wavelength: 3-25 µm. Power: 110V, 50/60Hz. Settings: High/Low power, 10-90 min timer. Features: heat-dissipating fan, temperature control sensor, tip-over protection. Dimensions: 28x20x33.5 cm; Weight: 2.8 kg. Standalone device.

Indications for Use

Indicated for patients requiring temporary relief of minor muscle/joint pain, stiffness, arthritis-related joint pain, muscle spasms, minor sprains, and strains; also for increasing local circulation and muscle relaxation. Intended for over-the-counter use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• WSTM Far-Infrared Therapy Unit, Model # TY-101 Series (K080465)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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: | [phone] |
| Fax: | [phone] |
| Contact: | CHIH-WEN TSAI ([e-mail]) |

## 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,<br>Model # TY-101 Series |
|------------------------|----------------------------------------------------------|
| Manufacturer: | WS FAR IR MEDICAL TECHNOLOGY<br>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<br>K160849 | Predicate device<br>K080465 | | Rationale |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Proprietary name | WSTM Far-Infrared<br>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<br>Unit, Model:<br>KP-B210, may be<br>used for the<br>temporary relief of<br>minor muscle and<br>joint pain and<br>stiffness, the<br>temporary relief of<br>minor joint pain<br>associated with<br>arthritis, the | The WSTM therapy units,<br>ty-101n and ty-101f may<br>be used for the temporary<br>relief of minor muscle<br>and joint pain and<br>stiffness, the temporary<br>relief of minor joint pain<br>associated with arthritis,<br>the temporar increase in<br>local circulation where<br>applied and relaxation of<br>muscles. In addition, the<br>lamp may also help | | IFU of subject device<br>is within the scope of<br>the predicate device |
| | temporary increase in<br>local circulation<br>where applied, and<br>relaxation of muscles.<br>In addition, the lamp<br>may also help muscle<br>spasms, minor sprains<br>and strains. | muscle spasms, minor<br>sprains, and strains, and<br>minor muscular back pain | | |
| Principle of Operation | Far Infrared (FIR)<br>radiation plate<br>included in the<br>proposed device is<br>composed of delicate<br>ceramic plate ( $Al_2O_3$ ),<br>heating element<br>(Electronic pastes),<br>FIR emitting material<br>(Dielectric pastes)<br>and silver electrode<br>(conductor pastes),<br>and can emit energy<br>in the infrared<br>spectrum (3~25 µm). | FIR emitting component,<br>composed of delicate<br>ceramic plate, heating<br>element, and high IR<br>emissivity mineral<br>mixture (such as silicon,<br>calcium, chromium,<br>copper, carbon etc.) to<br>emit energy in<br>the infrared spectrum<br>(3~25 µm) | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Key component | Far Infrared (FIR)<br>radiation plate<br>included in the<br>proposed device is<br>composed of delicate<br>ceramic plate ( $Al_2O_3$ ),<br>heating element<br>(Electronic pastes),<br>FIR emitting material<br>(Dielectric pastes)<br>and silver electrode<br>(conductor pastes) | FIR emitting component<br>composed of<br>delicate ceramic plate,<br>heating element,<br>and high IR emissivity<br>mineral mixture. | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Location | Forearm | Entire body | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>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<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Enclosure Leakage<br>current | <0.05 mA | <0.05 mA | Same | |
| Fuse | 1A | 2A | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject 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 not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Distance of radiation | 15-30 cm | 15-30 cm | Same | |
| Power density of<br>irradiated area | 10-20 mW/cm² | 20-30 mW/cm² | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Power consumption | <100 watts | <200 watts | Different but does not<br>adversely impact<br>safety and<br>effectiveness of<br>subject device | |
| Temperature at heating<br>surface | High 230 ± 15°C<br>Low 180 ± 10°C | High 230 ± 15°C<br>Medium 200 ± 15°C<br>Low 180 ± 10°C | Similar | |
| Recommended Time of<br>radiation | 20-40 mins | 20-40 mins | Same | |
| Storage environment | Temp: -15°C – 50°C<br>RH: 10% - 90% | Temp: -15°C – 70°C<br>RH: 10% - 90% | Same | |
| Shipping environment | Temp: -15°C – 70°C<br>RH: 10% - 90% | Temp: -15°C – 70°C<br>RH: 10% - 90% | Same | |
| Operation environment | Temp: 10°C – 30°C<br>RH: 10% - 90% | Temp: 10°C – 40°C<br>RH: 10% - 90% | Similar | |
| Emitter Use Life | 3000 hours | 1000 – 1500 hours | Does not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| Product Shelf Life | 5 years | 3 years | Does not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| Size | Length: 28 cm<br>Width: 20 cm<br>Height: 33.5 cm | Emitter:<br>30 x 25 x12 cm<br>Supporting arm:<br>75 x 15 x 4 cm<br>Control Box:<br>26 x 25 x 20 cm<br>Base: 60 cm diameter | Does not adversely<br>impact safety and<br>effectiveness of<br>subject device | |
| Weight | 2.8 Kg/Set | 13.3 Kg/set<br> | 14.0 Kg/set<br>Does not adversely<br>impact safety and<br>effectiveness of | |
| | | | | subject device |
| Cooling fan | Emitter with heat<br>dissipating fan and<br>temperature control<br>sensor switch | N/A | Emitter<br>with heat<br>dissipating<br>fan and<br>temperature<br>control<br>sensor<br>switch | Same |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

#### 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.