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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4.

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3.

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Auto1 or Auto1 or Auto 4.

To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes 1 and 3 or Auto 1, Auto 2, Auto 3, or Auto 4.

Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the T1040 aka Aurawave device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

The letter does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given text. The document is strictly a regulatory approval and does not detail the technical performance studies or the clinical trial data that would contain the requested information.

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