(247 days)
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.
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Dohenes Electrical Stimulators." It certifies that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The document is a regulatory approval, not a technical report detailing the performance evaluation of the device. It focuses on the administrative process of demonstrating substantial equivalence, which primarily relies on comparing the new device's technological characteristics and intended use to an already approved predicate device.
To answer your request, I would need a different type of document, such as:
- A clinical study report
- A design validation report
- A performance testing report
- The 510(k) submission itself (which might contain such details in its testing sections)
Without such a document, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth, or expert qualifications.
§ 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).