HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL

K063568 · Suzhou Medical Appliance Factory · ILY · Mar 22, 2007 · Physical Medicine

Device Facts

• Record ID: K063568
• Device Name: HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL
• Applicant: Suzhou Medical Appliance Factory
• Product Code: ILY · Physical Medicine
• Decision Date: Mar 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HWATO TDP Heat Lamp, including TDP11-DL, TDP12-XL, and TDP-22XL, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

HWATO TDP Heat Lamp (models TDP11-DL, TDP12-XL, TDP-22XL) is an infrared lamp device. It emits infrared spectrum energy to provide topical heating. Used in clinical or home settings to elevate tissue temperature, increase local blood circulation, and provide temporary relief for minor muscle/joint pain, stiffness, spasms, sprains, strains, and minor muscular back pain. Operated by patients or healthcare providers. Device provides therapeutic heat via infrared emission; no complex software or algorithmic processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared lamp; emits infrared spectrum for topical heating. Device consists of heating element/lamp assembly. No software, connectivity, or complex electronic algorithms. Class II device under 21 CFR 890.5500.

Indications for Use

Indicated for patients requiring topical heating to elevate tissue temperature, increase local blood circulation, and provide temporary relief of minor muscle/joint pain, stiffness, muscle spasms, sprains, strains, and minor muscular back pain.

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.

Submission Summary (Full Text)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2007

Suzhou Medical Appliance Factory % Scientific Health Care, Inc. Mr. Henry Woo Official Correspondent 1491Baker Street, Suite 1 Costa Mesa, California 92626

Re: K063568

Trade/Device Name: HWATO TDP Heat Lamp, Models TDP11-DL, TDP12-XL and TDP-22XL Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 26, 2007 Received: March 12, 2007

Dear Mr. Woo:

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

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

## Page 2 - Mr. Henry Woo

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. 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Additional Information for Hwato TDP Heat Lamp

## INDICATIONS FOR USE

K063568 510(K) Number (if known)_

Device Name: Infrared Lamp

Indications for use:

HWATO TDP Heat Lamp, including TDP11-DL, TDP12-XL, and TDP-22XL, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Radl

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

**510(k) Number** K063568