(179 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 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
I am sorry, but the provided text from the FDA 510(k) K141299 letter for the "OTC Combo TENS/EMS System, model WL-2405" does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a letter from the FDA determining substantial equivalence for the device. It focuses on regulatory classifications, general controls, and the indications for use. It does not detail performance specifications, clinical study results, or the methodological specifics of any studies conducted by the manufacturer to demonstrate safety and effectiveness.
Therefore, I cannot provide the requested table and points, as the information is not present in the document.
§ 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).