(202 days)
TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drugfree pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.
Not Found
This is a 510(k) clearance letter for the FDTENS 2010 device, a Transcutaneous Electrical Nerve Stimulation (TENS) unit. The document states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for the FDTENS 2010.
Therefore, I cannot populate the requested table or answer the specific questions about the study design or results. The document is solely a regulatory clearance letter, not a performance report or study summary.
§ 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).