TH0R DDII IR LAMP SYSTEM

K033923 · Thor Intl. · ILY · Mar 17, 2004 · Physical Medicine

Device Facts

• Record ID: K033923
• Device Name: TH0R DDII IR LAMP SYSTEM
• Applicant: Thor Intl.
• Product Code: ILY · Physical Medicine
• Decision Date: Mar 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

THØR DDII IR Lamp System is a portable, AC/battery-operated, noninvasive infrared lamp. Device consists of a drive unit/power supply housing electronics and controls, with optional cluster probes containing visible and infrared radiating elements. System is placed directly on skin to provide continuous heat therapy at a fixed frequency. Used to elevate tissue temperature for pain relief, increased circulation, and muscle relaxation. Operated by healthcare providers or patients (implied by topical application). Device transforms electrical energy into infrared/visible light energy to generate topical heat. Benefits include temporary symptomatic relief of musculoskeletal conditions.

Clinical Evidence

Bench testing only. Testing included functional performance testing and electrical safety testing. No clinical data provided.

Technological Characteristics

Infrared lamp (21 CFR 890.5500). Utilizes infrared diodes for topical heating. Portable, AC and battery-operated. Consists of a drive unit/power supply and optional cluster probes. Fixed frequency output. Noninvasive.

Indications for Use

Indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasm; temporary increase in local blood circulation; and temporary relaxation of muscle.

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

• Super Nova / Acubeam systems (Light Force Technology, Inc.)
• BioFlex Professional Therapy System (Meditech International, Inc.)

Submission Summary (Full Text)

{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: [phone] Facsimile: [phone] Email: [e-mail]

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,

{1}------------------------------------------------

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.

{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" 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.

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

# 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

Page 1 of 1