Search Results

The Innovative Med Multi Wave Light Therapy System is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Innovative Med Multi Wave Light Therapy System

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Innovative Med Multi Wave Light Therapy System." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.

It's a regulatory approval letter for a light therapy system, classifying it as an "Infrared lamp" (product code ILY), and indicating that it is substantially equivalent to predicate devices. The letter outlines the intended use for topical heating, temporary relief of minor muscle and joint pain, relieving stiffness, promoting muscle relaxation, and temporarily increasing local blood circulation.

Therefore, I cannot fulfill your request based on the provided text. The requested information pertains to clinical performance evaluation of a device, usually found in a clinical study report or a different section of a 510(k) submission that contains performance data, which is not present in this regulatory correspondence.

Ask a specific question about this device