Quell 1.0

GUDID 00851221006766

Standard Band for 1.0 Device

NEUROMETRIX, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00851221006766
• NIH Device Record Key: 34686249-b5c4-48ab-b99e-c5e6f52db918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quell 1.0
• Version Model Number: QE-BK-AGN
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

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 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210046

FDA Product Code

• QSQ: Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

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

Devices Manufactured by NEUROMETRIX, INC.

• 00851221006513 - Quell Fibromyalgia: 2025-08-11 Standard Band for 2.0 Device
• 00851221006520 - Quell Fibromyalgia: 2025-08-11 Quell 12-Month Electrode Kit (Regular) - 12 sleeves of Electrodes
• 00851221006551 - Quell Fibromyalgia: 2025-08-11 Quell 12-Month Electrode Kit (Sport)
• 00851221006704 - Quell: 2025-08-11 Extension Band
• 00851221006735 - Quell 2.0: 2025-08-11 Small Band for 2.0 Device
• 00851221006742 - Quell 2.0: 2025-08-11 Large Band for 2.0 Device
• 00851221006766 - Quell 1.0: 2025-08-11Standard Band for 1.0 Device
• 00851221006766 - Quell 1.0: 2025-08-11 Standard Band for 1.0 Device
• 00851221006803 - Quell 2.0: 2025-08-11 Quell 2.0 Relief Replacement Device (OTC)