(90 days)
Transcutaneous Electrical Nerve Stimulaton (TENS) devices are to be used for the symptomatic relief and management of chronic (long term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Premier A-P," which is a Transcutaneous Electrical Nerve Stimulation (TENS) device. The letter states that the device is substantially equivalent to devices marketed before May 28, 1976.
Based on the provided document, the following questions cannot be answered as the document is an FDA clearance letter and does not contain detailed study information regarding acceptance criteria or device performance. This type of information is typically found in the 510(k) submission summary or a separate clinical study report, neither of which are provided here.
Therefore, for all the items requested (1 to 9), the answer is: The information is not available in the provided FDA 510(k) clearance letter.
§ 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).