(30 days)
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 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 chromic, intractable pain associated with arthritis. (Choose TENS Mode 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
I apologize, but the provided text is a 510(k) clearance letter from the FDA for a TENS/EMS device. It primarily discusses the device's regulatory classification, its substantial equivalence to predicate devices, and its indications for use.
Crucially, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications. These details would typically be found in the accompanying 510(k) submission summary or clinical study reports, which are not provided in this document.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely 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).