(114 days)
Not Found
Not Found
No
The 510(k) summary describes a simple infrared heat lamp and does not mention any AI or ML components or functionalities.
Yes
The device is intended to provide topical heating to elevate tissue temperature, temporarily increase local blood circulation, and temporarily relieve minor muscle and joint pain and stiffness, as well as minor pain associated with muscle spasms, sprains, strains, and muscular back pain, which are all therapeutic purposes.
No
The provided text describes the device's function as providing therapeutic heating for pain relief, not for diagnosing medical conditions.
No
The device description clearly identifies the device as an "infrared lamp," which is a hardware component, not software.
Based on the provided information, the HWATO TDP Heat Lamp is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides topical heating for therapeutic purposes (relieving pain, increasing blood circulation). This involves applying energy to the body, not analyzing samples taken from the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The HWATO TDP Heat Lamp does not perform this function.
The device described is a therapeutic device that applies heat externally to the body.
N/A
Intended Use / 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.
Product codes
ILY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter use (21 CFR 801 Subpart C)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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 (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
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