(137 days)
- Specific indications: it is used for the symptomatic relief and management . of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- . Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Sandidad Health-Up TENS MP-73725," which is a Transcutaneous Electrical Nerve Stimulator (TENS).
Based on the content of this document, none of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies is available.
This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation. It confirms that the device has been found substantially equivalent to legally marketed predicate devices, but it does not detail the technical or clinical performance data that would typically be associated with the questions asked.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or any of the other requested study-specific 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).