Pain Management

GUDID 04719871186015

Analytical non-scalp cutaneous electrode A non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) and connected to an appropriate parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), impedance pneumography (IP)]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small cup/disk with a conductive surface and may include a length of insulated connecting wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

Analytical non-scalp cutaneous electrode

• Primary Device ID: 04719871186015
• NIH Device Record Key: b63267bc-3373-4302-a1a2-8cdfe85d22c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pain Management
• Version Model Number: HC-890A
• Company DUNS: 657383535
• Company Name: EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871186015 [Primary]

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

On-Brand Devices [Pain Management]

• 04719871184752: Cutaneous Electrode Pad
• 04719871184745: Cutaneous Electrode Pad
• 04719871184738: Cutaneous Electrode Pad
• 04719871184721: Cutaneous Electrode Pad
• 04719871184714: Cutaneous Electrode Pad
• 04719871184707: Cutaneous Electrode Pad
• 04719871186008: Cutaneous Electrode Pad
• 04719871185995: Cutaneous Electrode Pad
• 04719871185988: Cutaneous Electrode Pad
• 04719871185971: Cutaneous Electrode Pad
• 04719871186015: Analytical non-scalp cutaneous electrode A non-sterile, electrical conductor designed to be atta