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For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P7)

For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.(Choose TENS Modes P1 through P7)

For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Modes P8)

For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

Not Found

This document is an FDA 510(k) clearance letter for a medical device, specifically a "Well Life Wireless TENS/EMS Stimulator." It is not a study report and therefore does not contain the detailed information required to answer the prompt regarding acceptance criteria and a study proving device performance.

The letter states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the applicant in their 510(k) submission, which typically includes performance data to demonstrate equivalence, but the details of that data and the acceptance criteria are not present in this regulatory letter itself.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not a detailed description of performance studies and acceptance criteria.

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