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• 1. To temporarily increase local blood circulation.
• 2. To temporarily reduce minor muscular pain.
• 3. To help induce relaxation of muscles.
• 4. To treat arthritis and fibrosis.
• 5. To provide topical heating.

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I am sorry, but based on the provided document, I cannot answer the request as the document does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the DermaMED System, which states that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It does not include details on specific device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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DYNA T-2000 Physical Therapy System

This document is a 510(k) clearance letter from the FDA for a device called the DYNA T-2000 Physical Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does not contain the information required to answer your questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, often in sections detailing performance data and clinical studies, which are not part of this clearance letter.

Therefore, I cannot provide the requested details based solely on the provided text.

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