TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D

K020851 · C&H International · ILY · Sep 23, 2002 · Physical Medicine

Device Facts

• Record ID: K020851
• Device Name: TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D
• Applicant: C&H International
• Product Code: ILY · Physical Medicine
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TDP CQG-111A/B. CQG-222A/B. CQG-270A/B and CQG-222D Heat Lamp 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

TDP infrared heating lamps emit topical heat via a mineral-coated curing plate; emission spectrum 1-25 microns. Device operates at 110V, 250-275W; features 60-minute timer, safety fuse, swivel heater, and safety grill. Models A/D utilize mechanical control; Model B utilizes electronic control. Used for temporary pain relief and increased local circulation. Intended for human application; operation involves positioning lamp to direct infrared emission at affected body area. Curing plate requires replacement after 1,500 hours of use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, performance specifications, and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Infrared heating lamp; mineral-coated curing plate (rare earth/minerals); emission spectrum 1-25 microns; 110V power; 250-275W output; mechanical or electronic timer/control system; safety fuse and grill; swivel heater design.

Indications for Use

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

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 Lamp (K003538)
• Firard II TDP Lamp (K960036)
• TDP Infrared Heat Lamp (K890556)
• Sacred Crane TDP Lamp CQ-27 (K991503)
• TDP Therapy (K875052)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 2 3 2002

# Pre-market Notification 510(K) Summary

#### Submitter Name and Address: 1.0

Mike Luo, President, Ph.D. C&H International Inc. 1202 Melford Drive Houston, TX 77077, USA Phone: [phone]; Fax: [phone]

Date Prepared: June 17, 2002 (revised from March 9, 2002)

#### 2.0 Name of Device:

Proprietary Name:

| Common/Usual Name: | |
|---------------------------|--|
| Product Code: | |
| Classification: | |
| 510(K) Number (if known): | |

TDP CQG-111A, CQG-111B, CQG-222A, CQG-222B, CQG-270A, CQG-270B, and CQG-222D Heat Lamps Infrared Heating Lamp, TDP CO-27 Lamp IL Y Class II K020851

#### Predicate Device: 3.0

The TDP Lamps with Model No.: CQG-111A/B, CQG-222A/B, CQG-270A/B and COG-222D are equivalent in design and performance to other brands of infrared heating lamps such as:

- . TDP CQ-27 Lamp, Lhasa Medical Inc., 510(K)K003538
- Firard II TDP Lamp, Helio Medical Supplies, 510(K)K960036 .
- TDP Infrared Heat Lamp, Toxicology Professionals, 510(K)K890556 .
- Sacred Crane TDP Lamp CQ-27, United Pacific Co., 510(K)K991503 ●
- TDP Therapy, I.E.C. Health Products, 510(K)K875052

#### 4.0 Description of the TDP Lamps:

The TDP CQG-111A/B, CQG-222A/B, CQG-270A/B and CQG-222D lamps can be used to emit topical heating to the body of human. The TDP Lamps are specially designed to use a curing plate that is made of a rare earth and minerals. Emission spectrum ranges from 1 to 25 microns. The life of emission curing plate is 1,000 to 1,500 hours. When the curing plate is used up to 1,000 hours, the treatment effect of the curing plate will gradually depressed. After the curing plate is used for 1,500 hours, it should be replaced with a new one. The device manufactured for the United States of America uses 110 volts power and 250 (or 275) watts. All models have 1 safety fuse, 4-swivel heater and a safety grilling

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

020851 page 2 of 2

cover. All models include a 60-minutes timer. Only difference between Model "A" (or "D") and Model "B" is the control system. Model "A" (or "D") TDP is controlled with a mechanical system, but Model "B" TDP is controlled with an electronic system.

The TDP Lamps may be used for temporary relief of minor muscle, joint pain and stiffness, minor joint pain associated with arthritis, temporary increase in local circulation in the area that emission touches, and the temporary relaxation of muscles. The TDP lamps may also help to relief muscle spasms, minor sprains and strains, and minor muscular back pain.

The TDP Lamps manufactured by Chongqing Silicate Research Institute meets the general specifications, criteria, and effectiveness for heat lamps. The TDP Lamps also have the same technological characteristics as their predicate device such as TDP CQ-27 lamp.

#### 5.0 Manufactory:

The first TDP Lamp was invented by Chongging Silicate Research Institute (CSRI) in 1985. The former president of Chongqing Silicate Research Institute presented the TDP lamp at the 1986 Zagreb International Fair and the 1986 Brussels Eureka World Fair for Invention, and won a gold and a silver medal, respectively. Chongqing Silicate Research Institute submitted a patent application for the technology of the TDP lamp in 1987. The application was approved by Chinese Patent Bureau in December 1992. Before Nov. 1996, the TDP lamps marketed in the USA contained the curing plates manufactured by CSRI. After Nov. 1996, CSRI stopped supplying its curing plates to Chongqing Bashan Instrument Factory which is the manufacturer for most of TDP lamps marketed in the USA.

Signature,

Mike Luo

Mike Luo, President, Ph.D. C&H International Inc.

Date:

June 20, 2002

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. Above the profiles are three curved lines that resemble flowing hair or ribbons. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2002

Mike Luo, Ph.D., President C&H International Inc. 1202 Melford Drive Houston, Texas 77077

Re: K020851

Trade/Device Name: TDP Lamp, Models CQG-111A/B, CQG-222A/B/D, CQG-270A/B Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 20, 2002 Received: June 25, 2002

Dear Dr. Luo:

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 – Dr. Mike Luo

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

L. Mark H. Milherson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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

Applicant: C&H International Inc.

510(k) Number (if.known): K020851

Device Name: TDP CQG-111A/B, CQG-222A/B/D and CQG-270A/B Heat Lamp Indications For Use:

The TDP CQG-111A/B. CQG-222A/B. CQG-270A/B and CQG-222D Heat Lamp 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Mark A. Millner

sion of General, Restorative

(Division Sign-Off) Division of General, Restorative and Neurological Device

510(K) Number K020851

Prescription Use (Per 21 CFR 801.109) 510(k) Number .

and Nourological Devices

Over-The-Counter Use