(148 days)
Not Found
No
The device description and intended use focus on infrared heating and its therapeutic effects, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an "infrared heating system which emits topical heat to the human body for therapeutic applications" and its intended use is 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." These uses clearly indicate a therapeutic purpose.
No
This device is an infrared heating system intended for therapeutic applications like pain relief and muscle relaxation, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components including an IR emitter, control box, supporting arm, protection net, and a base. It is an infrared heating system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the temporary relief of pain, stiffness, and other physical ailments by applying topical heat to the human body. 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 therapeutic device, not a device used to examine specimens from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
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. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
ILY
Device Description
The WS™ THERAPY UNIT (Model # TY-101 series), is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3 ~ 25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net or the emitter to prevent fire or direct touch by the user. The entire unit is mounted on base that is easy to move. The device uses 110 Vac as power source . it meets the related requirement of IEC 60601-1 Electrical Safety.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 1 8 2008
510(K) SUMMARY
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 |
| County 231, Taiwan | |
| Phone: | +886-2-8219-2005 |
| Fax: | +886-2-8219-2009 |
| Contact: | Miss Ruth Pui / Overseas sales Administrator |
| 2. Device Name : | |
| Trade Name: | WS ™ THERAPY UNIT, |
| 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 |
| classified as | |
| Regulatory Class: II | |
| Product Code: ILY | |
| Panel : Physical Medicine | |
| Regulation Number: 21CFR 890.5500 | |
| 4. Predicate Device: | The predicate device is the |
| • TDP CQ-27 Heat Lamp (K003538) marketed by | |
| Lhasa OMS, Inc.. | |
| 5. Device Description: | The WS™ THERAPY UNIT (Model # TY-101 series), is |
| an infrared heating system which emits topical heat to the | |
| human body for therapeutic applications. It consists of an | |
| IR emitter (Emission spectrum ranges from 3 ~ 25 | |
| microns.), a control box, a supporting arm to allow for | |
| adjustment of the emitter locations, and a protection net or | |
| the emitter to prevent fire or direct touch by the user. The | |
| entire unit is mounted on base that is easy to move. The | |
| device uses 110 Vac as power source . it meets the related | |
| requirement of IEC 60601-1 Electrical Safety. | |
| 6. Intended 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. |
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.
2
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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041or (240) 276-3150 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
4
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
Page 1 of 1
(Division Sign Off) Division of General, Restorative, and Neurological Devices
510(k) Number