(192 days)
PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
The Axelgaard PALS® Neurostimulation reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS.
The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, strelchable conductive fabric, conductive hydrogel, and an electrode carrier distribution is delivered via a connector lead wire stripped to an additional length.
The provided document is a 510(k) summary for the Axelgaard PALS® Neurostimulation Electrodes. It is a premarket notification for a medical device seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies.
Therefore, the document explicitly states: "No performance data is required to support the proposed over-the-counter PALS® Neurostimulation Electrode as it has identical technical characteristics (including design) as compared to the predicate device."
Because no performance data or clinical studies are presented in this document to demonstrate the device meets specific acceptance criteria, I cannot provide the requested information. The 510(k) process for this device relies on the established safety and effectiveness of its predicate devices, not on new clinical trials for the subject device itself.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).