(309 days)
The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "UltraStim Kit." It confirms the device's substantial equivalence to predicate devices for its intended use. This type of document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) from this document. This letter is a regulatory approval notice, not a study report.
§ 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).