(89 days)
TENS (For model EM-6000, EM-6100 & EM-6300) : 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 B/N/M/S1/S2 adjustable mode & TENS Modes P to P6 for EM-6300).
EMS (For model EM-6000, EM-6200 & EM-6300): intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS C/S/A adjustable mode & EMS Modes P7 to P12 for EM-6300).
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria for a medical device or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a TENS/EMS device, confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and indications for use but does not detail performance acceptance criteria or specific study results to demonstrate those criteria are met.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.
§ 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).