(157 days)
TENS: intended for temporary relief of pain associated with sore and aching muscles in the low 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 B/N/M/SD1/SD2 as adjustable mode and P1 to P12 preset programs only for EV-906A).
EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes C/S/A as adjustable mode and P13 to P24 preset programs only for EV-906A).
Li-Battery powered OTC TENS/EMS Combination Stimulator, models EV-906/EV-906A.
I am sorry, but the provided text is a 510(k) clearance letter for a medical device and does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).