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PROTENS reusable, self-adhering, over-the-counter Cutaneous electrodes are indicated for use with electrical stimulation device. Some common types of electrical stimulation device include, but are not limited to, transcutaneous nerve stimulation (TENS), electrical muscle stimulation (EMS) device, Neuromuscular Electrical Stimulation (NMES/FES) device and Microcurrent electrical nerve stimulation (MENS), Interferential stimulation (IF). Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

This document is a 510(k) clearance letter from the FDA for Bio Protech Inc.'s PROTENS Reusable Stimulating Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot provide a response to your request as the document does not contain the necessary information.

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The Rhythmlink International Cutaneous Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating /recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a selfadhesive solid-gel surface. The electrodes are non-sterile and for single patient use only. These devices are restricted to sale by or on the order of a practitioner licensed by the Law of the State in which he/she practices.

Rhythmlink International Cutaneous Disposable Electrodes are single patient use, disposable devices. Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes consist of a cotton non-woven pad with a Silver/Silver Chloride carbon layer and a solid Hydro-qel adhesive laver. The electrodes are attached to a lead wire and terminate at the opposite end using a DIN 42-802 type safety connectors.

The provided text is a 510(k) summary for Rhythmlink International Cutaneous Pad Electrodes. It describes the device, its intended use, and its technological characteristics. However, it does not contain any information about acceptance criteria, specific performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies.

The document makes a declaration of "substantial equivalence" to a predicate device (Bio-logic Systems Corp, 510(k)#: K941799) and states: "The performance is expected to be the same as the predicate device. No new questions of performance, safety or effectiveness are raised." This statement implies that no specific new studies were conducted or deemed necessary to prove performance against specific acceptance criteria for this 510(k) submission.

Therefore, I cannot fulfill your request for the detailed table and study information because it is not present in the provided document. The 510(k) process for this device appears to rely on the established performance of the predicate device.

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