(256 days)
To be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
The provided text is a 510(k) clearance letter from the FDA for a medical device called the Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01. This type of document does not typically contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria.
510(k) clearances are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. While a manufacturer must perform testing to support their substantial equivalence claim, the FDA letter itself does not detail the testing methodology, acceptance criteria, or study results in the manner requested.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval, not on the technical performance study 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).