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Useful in symptomatic relief of pain caused by medically diagnosed arthritis, bursitis, and chronic joint inflammation.

Relaxes muscles, relieves stiffness and muscle spasm.

Stimulates circulation and for other conditions where heat is indicated.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Para-Care®". This document primarily focuses on the regulatory approval and indications for use of the device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for this specific document. The information you are looking for would typically be found in a clinical study report or a 510(k) submission summary that details the testing and validation of the device.

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