DIGITAL RING ELECTRDE

• K Number: K991771
• Device Name: DIGITAL RING ELECTRDE
• Manufacturer: NEURO SUPPLIES, INC.
• Date Cleared: 1999-08-18 ( 86 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Digital Ring Electrode is intended for non-invasive use as a recording electrode during electromyographic (EMG) recordings.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and an "Intended Use Statement" for a Digital Ring Electrode. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, it does not include details about:

• Acceptance criteria and reported device performance in a table format.
• Specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document discusses regulatory clearance, but not the technical study details you've asked for.

Regulation Number and Section

§ 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).