(29 days)
TENS (3-6, 13, 14, 20, 21, 23): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (1, 2, 7-12, 15-19, 22, 24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a TENS & PMS device. It details the regulatory clearance for the device but does not include any study data, acceptance criteria, or information regarding performance testing, sample sizes, ground truth establishment, or expert involvement in product validation.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or any of the other requested details about a study proving the device meets those criteria.
§ 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).