Surface (Cutaneous) Electrode for EMG

Full name

The Electrode Store Surface (Cutaneous) Electrode for EMG

510(k) Number

K020445 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• The Electrode Store

  Class I

  CE/MDR

• MedCare Visions

  Class IIa

  CE/MDD

• DPNCheck

  Class I

  CE/MDR GUDID on market

• Protectrode System

  Class II

  FDA 510(k) K926094 Active Cleared 6 Dec 1995

• Protectrode Systems Concentric

  Class II

  FDA 510(k) K932691 Active Cleared 16 Nov 1995

• Surface Electrode for Electroencephalography

  Class II

  FDA 510(k) K022197 Active Cleared 13 Aug 2002

See all devices from The Electrode Store →

• What types of muscle or nerve conditions can this electrode help diagnose when used in an EMG study?

  This surface (cutaneous) electrode is designed to record electrical activity from skeletal muscles during electromyography (EMG). It helps assess neuromuscular function, evaluate nerve integrity, and identify muscle disorders such as myopathies, neuropathies, or other conditions affecting muscle signaling. By capturing and transmitting muscle signals, clinicians can diagnose issues like nerve compression, muscle wasting, or abnormal electrical patterns linked to these conditions.

• Is this electrode reusable, or is it meant for single-use only? How does that affect its clinical use?

  This electrode is explicitly supplied as a single-use, sterile disposable device, meaning it is intended for one-time clinical use only. This design reduces the risk of cross-contamination between patients, ensuring hygiene and safety in electrodiagnostic settings. After use, it must be disposed of following standard biomedical waste protocols, as reuse is not recommended or supported by the manufacturer.

• What storage conditions should be followed to maintain the electrode’s performance and sterility?

  To preserve sterility and performance, the electrode must be stored in a dry environment, protected from moisture and extreme temperatures. Exposure to humidity or temperature fluctuations could compromise its adhesive properties or integrity, potentially affecting signal quality during use. Always check the packaging for expiration dates and store in the original sealed container until ready for clinical application.

• Are there different sizes or models available for this electrode, and how would a clinician choose the right one?

  The provided data does not specify multiple sizes or models for this electrode, implying it is likely offered in a standardized design suitable for general cutaneous EMG applications. Clinicians should refer to the manufacturer’s instructions or product documentation for guidance on proper placement and sizing based on the patient’s anatomy and the specific muscles being assessed. If specialized applications are needed, additional product variants may exist but are not detailed in the current submission.