THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG

• K Number: K020445
• Device Name: THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
• Manufacturer: THE ELECTRODE STORE, INC.
• Date Cleared: 2002-05-10 ( 88 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The Electrode Store™ Surface Cutaneous Electrode for EMG is indicated for non-invasive use as recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for a medical device and not a study. The document confirms that "The Electrode Store™ Surface (Cutaneous) Electrode for EMG" is substantially equivalent to legally marketed predicate devices.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. This letter is a regulatory compliance document, not a clinical study report. It does not contain data or design information regarding a clinical investigation to assess performance against specific acceptance criteria.

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).