Quell Electrode

GUDID 00851221006834

Electrode Replacement (Sport)

NEUROMETRIX, INC.

Electrode conductive medium

• Primary Device ID: 00851221006834
• NIH Device Record Key: 0b657b1e-a8c1-40a2-80fe-bb8f5773c7cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quell Electrode
• Version Model Number: QE-P02-RPL
• Company DUNS: 957536014
• Company Name: NEUROMETRIX, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocore.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140586

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: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [Quell Electrode]

• 00851221006834: Electrode Replacement (Sport)
• 00851221006827: Quell Electrode Replacement (Regular)