(114 days)
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.
Not Found
This document is a 510(k) premarket notification from the FDA, approving the HWATO TDP Heat Lamp. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Identification: HWATO TDP Heat Lamp, Models TDP11-DL, TDP12-XL and TDP-22XL.
- Regulatory Classification: Class II, Infrared lamp (21 CFR 890.5500).
- Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: Emits infrared spectrum to provide topical heating for elevating tissue temperature, temporarily increasing local blood circulation, and temporarily relieving minor muscle and joint pain and stiffness, minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.
- Marketing Authorization: Allows the manufacturer to market the device.
Since the document is a 510(k) approval letter, it confirms that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device that does not require premarket approval. The FDA's substantial equivalence determination does not typically involve the presentation of new clinical study data with specific acceptance criteria in the approval letter itself. Such data, if any were submitted, would be part of the full 510(k) submission, which is not provided here.
Therefore, I cannot provide the requested information from this document.
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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
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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 (240) 276-0120. 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 (240) 276-3150 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
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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
N/A