(311 days)
TENS The symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain.
Vibration Relaxing muscles and relieving minor aches and pains.
Heat Lamp Emits energy at infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the ElectroPulse device. It states that the device is substantially equivalent to legally marketed predicate devices. This type of letter does not typically contain information about comprehensive clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, which are usually part of a full clinical trial report or a more detailed submission.
Based on the provided text, the specific information requested cannot be extracted. The document confirms the FDA's clearance of the device based on substantial equivalence, implying that the performance of the ElectroPulse is considered comparable to similar devices already on the market, but it does not detail a study conducted by the applicant to prove specific acceptance criteria for the device itself.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study details as this document is not a clinical 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).