(253 days)
The Palm TENS is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
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The provided text is a 510(k) clearance letter from the FDA for a device called "Palm TENS." This document grants market clearance based on substantial equivalence to a predicate device. It addresses regulatory matters but does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth, as none of that information is present in the provided FDA letter. The letter is a regulatory approval, not a scientific 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).