(272 days)
The Quickels QS 200 device is intended for use as a device to provide a firm and reliable attachment of an AgCl sk in surface electrode to a patient or subject being dur ing measured standard electrocardiography workups. The electrodes can be reused.
The Quickels QS 200 System is a device that allows reusable AgCl electrodes be attached to the skin surface to using Suction rather than an adhesive.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, its intended use, and technological characteristics, as well as a comparison to predicate devices, but it does not include any details on acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert involvement. This document appears to be a 510(k) summary for device clearance rather than a clinical study report.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.