(136 days)
The Everyway EV-820 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
The Everyway EV-820 OTC Pain Relief TENS is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.
The Everyway EV-820 OTC Pain Relief TENS consists mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Everyway EV-820 OTC Pain Relief TENS is pre-program modes with fixed pulse width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simple design change from the pre-program modes of comparison clear model, existing 510(k) cleared devices, Low Back Pain Relief System/ Model EV-820(K110716). Every operation mode of Everyway EV-820 OTC Pain Relief TENS Syste has its individual stimulation operation cycle.
I am unable to provide a description of acceptance criteria and a study that proves the device meets the acceptance criteria from the provided document. The document is a 510(k) premarket notification letter from the FDA to Everyway Medical Instruments Co., Ltd. regarding their Everyway EV-820 OTC Pain Relief TENS device.
Here's why I cannot fulfill your request based on the provided text:
- No specific acceptance criteria are stated: The document primarily focuses on establishing substantial equivalence to predicate devices based on regulatory classification, intended use, and technological characteristics. It does not define specific performance metrics or acceptance criteria for the device itself (e.g., pain reduction percentage, battery life benchmarks).
- No detailed study is presented to prove acceptance criteria: The document explicitly states: "No particular Clinical Test was conducted for Everyway EV-820 OTC Pain Relief TENS." It mentions compliance with voluntary standards (IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2) and software verification, which are non-clinical tests for safety and performance, but these are not presented as studies designed to prove specific acceptance criteria for the device's therapeutic effectiveness. The comparison tables provided highlight characteristics, not performance against acceptance criteria.
- The document is a regulatory submission, not a research paper: A 510(k) summary aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a detailed clinical study proving device effectiveness against pre-defined acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document.
§ 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).