(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.
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This document is a 510(k) clearance letter for the Medisana Digital TENS device, not a study report or technical specification detailing acceptance criteria and performance data. Therefore, the information requested in the prompt cannot be extracted from the provided text.
The document confirms that the device is substantially equivalent to legally marketed predicate devices for the indications specified (treatment of chronic, acute, or post-operative pain using Transcutaneous Electrical Nerve Stimulation), allowing it to be marketed. It does not contain details about specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
§ 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).