Search Results

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.

Ask a specific question about this device