(106 days)
Conductive silicone rubber electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive silicone rubber electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.
Conductive Silicone Rubber Electrode
This document is an FDA clearance letter for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information would typically be found in the device's technical specifications, design validation reports, or clinical study summaries, which are not part of this FDA clearance notification.
Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the FDA has determined the "Conductive Silicone Rubber Electrode" device is substantially equivalent to legally marketed predicate devices.
§ 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).