Search Results

All four devices are indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the MR4 Multi Radiance Therapy System and its accessories. This type of document establishes substantial equivalence to a predicate device and permits marketing. It outlines the regulatory classification and general controls.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.
Specifically, the requested information about device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details is completely absent from the provided text.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input, as the necessary information is not present.

Ask a specific question about this device