(213 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.
Sanidad TENS-Duo Mode GP8016N
This document is a 510(k) premarket notification decision letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the device's substantial equivalence to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested table and study details. This document is purely administrative approval based on substantial equivalence, not a detailed technical report of device performance or clinical trials.
§ 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).