WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES

K080465 · Ws Far IR Medical Technology Co., Ltd. · ILY · Jul 18, 2008 · Physical Medicine

Device Facts

• Record ID: K080465
• Device Name: WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
• Applicant: Ws Far IR Medical Technology Co., Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The WS TM 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 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.

Device Story

Infrared heating system emitting topical heat (3-25 micron spectrum) to human body; consists of IR emitter, control box, adjustable supporting arm, and protective net; mounted on mobile base. Powered by 110 Vac. Used for therapeutic application of heat to alleviate pain, stiffness, and muscle spasms; increases local circulation. Operated by user or clinician in various settings. Healthcare provider uses device to provide non-invasive thermal therapy; output is direct infrared heat application. Benefits patient through temporary pain relief and muscle relaxation.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility) standards.

Technological Characteristics

Infrared heating lamp; emission spectrum 3-25 microns; 110 Vac power source; adjustable supporting arm; protective net; mobile base. Conforms to IEC 60601-1 and IEC 60601-1-2 standards.

Indications for Use

Indicated for temporary relief of minor muscle/joint pain, stiffness, arthritis-related joint pain, muscle spasms, minor sprains/strains, and minor muscular back pain; also for temporary increase in local circulation and muscle relaxation. Suitable for OTC 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

• TDP CQ-27 Heat Lamp (K003538)

Submission Summary (Full Text)

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JUL 1 8 2008

## 510(K) SUMMARY

K080465

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

| 1. Submitter's Name: | WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2F, No. 4, Lane 130, Mincyuan Rd., Sindian City, Taipei<br>County 231, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Miss Ruth Pui / Overseas sales Administrator |
| 2. Device Name : | |
| Trade Name: | WS ™ THERAPY UNIT,<br>Model # TY-101 series |
| Common Name: | Infrared Heating Lamp |
| Classification name | Lamp, Infrared |
| 3. DEVICE CLASS | WS™ THERAPY UNIT (Model # TY-101 series) have been<br>classified as<br>Regulatory Class: II<br>Product Code: ILY<br>Panel : Physical Medicine<br>Regulation Number: 21CFR 890.5500 |
| 4. Predicate Device: | The predicate device is the<br>• TDP CQ-27 Heat Lamp (K003538) marketed by<br>Lhasa OMS, Inc.. |
| 5. Device Description: | The WS™ THERAPY UNIT (Model # TY-101 series), is<br>an infrared heating system which emits topical heat to the<br>human body for therapeutic applications. It consists of an<br>IR emitter (Emission spectrum ranges from 3 ~ 25<br>microns.), a control box, a supporting arm to allow for<br>adjustment of the emitter locations, and a protection net or<br>the emitter to prevent fire or direct touch by the user. The<br>entire unit is mounted on base that is easy to move. The<br>device uses 110 Vac as power source . it meets the related<br>requirement of IEC 60601-1 Electrical Safety. |
| 6. Intended Use: | The WS TM THERAPY UNITS, TY-101N and TY-101F, may be<br>used for the temporary relief of minor muscle and joint<br>pain and stiffness, the temporary relief of minor joint pain<br>associated with arthritis, the temporary increase in local<br>circulation where applied, and relaxation of muscles. In<br>addition, the lamp may also help muscle spasms, minor<br>sprains and strains, and minor muscular back pain. |

Section 4 – 510(k) Summary REV.【B1】 Page 1 of 2

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- The device conforms to applicable standards includes IEC 7. Performance 60601-1, IEC 60601-1-2 & related standards----etc. Summary:
## 8. Conclusions:

The WS™ THERAPY UNIT (Model # TY-101 series) has the same intended use and similar technological characteristics as the TDP CQ-27 Heat Lamp (K003538) marketed by Lhasa OMS, Inc.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the ws™ THERAPY UNIT (Model # TY-101 series) is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WS Far IR Medical Technology Corporation % Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 N Boldt Drive Flagstaff, Arizona 86001

JUL 1 8 2008

Re: K080465

Trade Name: WS Far Infrared Therapy Unit, Model # TY-101 Series Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: May 27, 2008 Received: May 27, 2008

Dear Ms. Reich:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Jennifer Reich

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone]or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K#080465

Device Name: WSTM THERAPY UNIT, Model # TY-101 series WS Far IR Medical Technology Co., Ltd.

Indications for Use:

The WS™ 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 temporary increase in local circulation where applied, and relaxation of cemporal y increason, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use V (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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(Division Sign Off) Division of General, Restorative, and Neurological Devices

510(k) Number