Myocene Electrode

GUDID 05430004268017

An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.

Myocene

Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 05430004268017
• NIH Device Record Key: c3e25976-ee43-4888-b449-aec217be150d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myocene Electrode
• Version Model Number: 1
• Company DUNS: 372401437
• Company Name: Myocene
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430004268017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132998

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: 2025-05-02
• Device Publish Date: 2025-04-24

Devices Manufactured by Myocene

• 05430004268017 - Myocene Electrode: 2025-05-02An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.
• 05430004268017 - Myocene Electrode: 2025-05-02 An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli thro
• 05430004268000 - Myocene: 2025-04-25 The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches