(157 days)
Not Found
No
The device description and performance studies focus on infrared heat therapy and do not mention any AI or ML components or capabilities.
Yes
The device is indicated for the temporary relief of minor muscle and joint pain, stiffness, muscle spasms, strains, sprains, and muscular back pain, as well as muscular relaxation and temporary increase of local circulation. These are all therapeutic benefits.
No
This device is a therapeutic device that provides heat therapy for pain relief and increased circulation. Its intended uses do not involve diagnosing any medical conditions.
No
The device description explicitly states that the system consists of an outer application cover with adjustable pads that enclose infrared heating elements, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the temporary relief of pain and stiffness, muscle relaxation, and increased local circulation. These are all therapeutic applications applied directly to the patient's body.
- Device Description: The device description details a system that provides infrared heat to the patient's body using pads and heating elements. This is a physical therapy device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not applied to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
IRT, ILY
Device Description
The Thermotex Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nylon-cotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
different areas of the patient's body
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)
The manufacturer has evaluated the pad's performance during laboratory bench testing and animal studies to demonstrate infrared radiation capability and its safety. The manufacturer has conducted preclinical bench and animal testing with the Thermotex heat pads. The information from laboratory and animal testing documents that the technological differences between the Thermotex Heat Therapy Systems and the predicate device do not raise new questions of safety and effectiveness.
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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ATTACHMENT E
510(k) SUMMARY
| 510(k): | K092589 |
|---|---|
| Trade Name: | Thermotex Heat Therapy Systems |
| Sponsor: | EAS Consulting Group LLC. |
| 1940 Duke Street, Suite 200 | |
| Alexandria, VA 22314 | |
| Fax- 703.684.4428 | |
| Device Generic Name: | Electric Heating Pad and Infrared Lamp |
| Classification: | CFR 890.5740 Class II |
JAN 2 8 2010CFR 890.5500 Class II
IRT, ILY Product Code:
Product Description:
The Thermotex Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nylon-cotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
Indications for Use:
The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Predicate Devices:
The Thermotex Heat Therapy Systems is substantially equivalent to BIO-MAT 2000 (K072534) - Rich Way International Inc.
Technological Characteristics
The Thermotex Heat Therapy Systems are electrically-powered pads that generate infrared radiation to apply heat to affected body areas. The user can control the pad's heat mrarou raintente to the body by means of a 3-position switch. The manufacturer has evaluated the pad's performance during laboratory bench testing and animal studies to demonstrate infrared radiation capability and its safety.
1
Substantial Equivalence
The Thermotex Heat Therapy Systems have the same intended use and indications for use as its predicate device. The manufacturer has conducted preclinical bench and animal testing with the Thermotex heat pads. The information from laboratory and animal testing documents that the technological differences between the Thermotex Heat Therapy Systems and the predicate device do not raise new questions of safety and effectiveness.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head facing to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Thermotex Therapy Systems, Ltd. % EAS Consulting Group LLC Mr. Eduardo March 1940 Duke Street, Suite 200 Alexandria, Virginia 22314
JAN 2 8 2010
Re: K092589
Trade/Device Name: Thermotex Heat Therapy Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, IRT Dated: January 25, 2010 Received: January 26, 2010
Dear Mr. March:
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
3
Page 2 - Mr. Eduardo March
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Thermotex Heat Therapy Systems
Page _______ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K092589
Device Name: THERMOTEX HEAT THERAPY SYSTEMS
Indications for Use:
The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associaed with arthritis, muscle spasms, minor strains and sprains and minor muscular back air: muscular relaxation; and the temporary increase of local circulation where wained.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND / OR
Over-the -Counter Use × (PART 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| (Division Sign-Off) | FOR M. MELKERSON |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K092589 |