(90 days)
Not Found
Not Found
No
The description focuses on the physical components and function of a heat lamp, with no mention of AI/ML terms or capabilities.
Yes
The device is described as providing "topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle," which are therapeutic claims.
No
The device is described as providing topical heating for pain relief and increased blood circulation, which are therapeutic functions, not diagnostic ones. It does not mention analyzing or detecting any medical conditions.
No
The device description explicitly states it is a "portable, AC and battery operated noninvasive, low level infrared lamp" and consists of a "Drive Unit/Power Supply" and "optional treatment probes," which are 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 that the device is for providing topical heating to the body for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This is a direct treatment application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a lamp system that emits energy for heating. This aligns with a physical therapy or therapeutic device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The THØR IR Lamp System is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle,
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The THØR DDII IR Lamp System is a portable, AC and battery operated noninvasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency. The System consists of a Drive Unit/Power Supply that houses the electronics and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Testing of the THØR DDII IR Lamp System included functional performance testing and electrical safety testing.
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.
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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.
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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).
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§ 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
MAR 1 7 2004
ecember 9, 2003.
K033923
16F2
APPENDIX B
510(k) PREMARKET NOTIFICATION SUMMARY
(Per 21 CFR 807.92)
THØR DDII IR Lamp Systems
I. Applicant:
JHØR International Ltd. Caer Sidhe Chiltern Road Amersham HP6 SPH United Kingdom Telephone: +44 1494 433 736 Facsimile: +44 1494 431 481 Email: james@thorlaser.com
Key Contact: James Carrol
II. Device Name
| Proprietary Name: | THØR DD II IR Lamp System |
|---|---|
| Common / Usual Name: | Infrared Lamp |
| Classification Name: | Infrared Lamp (21 CFR 890.555) |
| Product Code: | ILY |
III. Predicate Device
The THØR DDII IR Lamp System is substantially equivalent to other infrared lamps currently in commercial distribution such as the Super Nova / Acubeam systems manufactured by Light Force Technology, Inc., and BioFlex Professional Therapy System manufactured by Meditech International, Inc.
IV. Intended Use of the Device
The THØR IR Lamp System is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle,
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Image /page/1/Picture/1 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text includes 'K033923' and 'JOF2', written in a slightly tilted orientation. The handwriting is somewhat stylized, with distinct and clear strokes, making the characters legible despite the handwritten form.
V. Description of the Device
The THØR DDII IR Lamp System is a portable, AC and battery operated noninvasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency. The System consists of a Drive Unit/Power Supply that houses the electronics and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit.
Summary of the Technical Characteristics of the Thor DDII IR Lamp VI. System as Related to the Referenced Predicate Devices.
The THØR DDII IR Lamp System and the aforementioned predicate devices are infrared lamps as clefined in 21 CFR 890.5500. These devices utilize infrared diodes to generate topical heating for the purpose of elevating tissue temperatures for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The Systems are intended to be placed directly on the skin to provide heating.
Testing VII.
Testing of the THØR DDII IR Lamp System included functional performance testing and electrical safety testing.
VIII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the THØR DDII IR Lamp System has the same intended uses, with similar functional and performance characteristics. The THØR DDII IR Lamp System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature' and accepted by the Federal Food and Drug Administration.
The THØR DDII IR Lamp System performs as intended and do not raise any new safety or efficacy issues.
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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" around the perimeter. Inside the circle is an abstract image of an eagle, represented by three stylized lines forming the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Thor International Ltd. C/o M. Joyce Heinrich Texas Applied Biomedical Services, Inc. 12101 - A Cullen Boulevard Houston, Texas 77047
Re: K033923
Trade/Device Name: Thor DDII IR Lamp System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 15, 2003 Received: January 16, 2004
Dear Ms. Heinrich:
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 - M. Joyce Heinrich
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 proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
R. Merle A. Millikan
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT C
INDICATIONS FOR USE
510(k) Number (if known): K033923
Device Name: THØR DDII IR Lamp System
Indications for Use:
The THØR DDII 1R Lamp System is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
AND/OR Prescription Use: X (Part 21 CFR 801 Subpart D)
Over the Counter Use: (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)
f
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K033923
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