(90 days)
Everyway Analog OTC TENS, model N601L is 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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document does not contain information on the acceptance criteria, study details, or performance metrics of the device as it would typically be presented in a clinical or validation study report.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than through a dedicated study demonstrating performance against specific clinical acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need access to the full 510(k) submission, device validation reports, or clinical study data if such studies were conducted and included in the submission.
§ 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).