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GM511TE & GM511T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19 and C/B/M/H1/H2 adjustable mode)

GM511TE & GM511T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM511TE & GM511E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16 and C/S/A adjustable mode)

GM510TE & GM510T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM510TE & GM510T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM510TE & GM510E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)

GM520TE & GM520T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM520TE & GM520T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10 )

GM520TE & GM520E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)

GM530TE & GM530T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM530TE & GM530T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM530TE & GM530E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)

GM540TE & GM540T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM540TE & GM540T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM540TE & GM540E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (ChooseEMS Modes P11 to P16)

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This document is a 510(k) premarket notification clearance letter from the FDA for the GEM-STIM OTC TENS/EMS System. It does not contain information about acceptance criteria or studies proving device performance. The letter primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This type of detailed performance data is typically found in the actual 510(k) submission, not in the clearance letter itself.

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