QUELL FIBROMYALGIA

GUDID 00851221006384

Prescription Starter Kit for Government Markets (includes 1 Device, 4 Packs of Quell Electrodes with UDI 00851221006018, 1 Charger, 1 Charger Cable, 1 Sport Band)

NEUROMETRIX, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00851221006384
• NIH Device Record Key: a9c613e4-044f-4910-b46a-18a2fe682021
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUELL FIBROMYALGIA
• Version Model Number: QE-FMG-4
• Company DUNS: 957536014
• Company Name: NEUROMETRIX, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.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
• 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	00851221006384 [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: 2024-07-25
• Device Publish Date: 2024-07-17

On-Brand Devices [QUELL FIBROMYALGIA]

• 00851221006612: Prescription Starter Kit (includes device, 1 pack of electrode with IDU 00851221006018, 1 charge
• 00851221006636: Quell Healthwarehouse Bundle - 3 Sport Electrode packs and 1 Standard Quell Band (3 pack sport e
• 00851221006629: Quell Healthwarehouse Bundle - 3 Standard Electrode packs and 1 Standard Quell Band (3 pack elec
• 00851221006674: Quell Sport Electrode One Year Refill for Government Markets (contains 4 packs of QE-ELG-P02 wit
• 00851221006667: Quell Standard Electrode One Year Refill for Government Markets (contains 4 packs of QE-ELG-P01
• 00851221006650: Prescription Starter Kit for HCP Offices (includes 1 Device, 2 Packs of Quell Electrodes with UD
• 00851221006643: Prescription Starter Kit for Government Markets (includes 1 Device, 2 Packs of Quell Electrodes
• 00851221006698: Quell Sport Electrode Bundle for Government Markets (3 Sport Quell Electrode packs with UDI 0085
• 00851221006681: Quell Standard Electrode Bundle for Government Markets (3 Standard Quell Electrode packs with UD
• 00851221006384: Prescription Starter Kit for Government Markets (includes 1 Device, 4 Packs of Quell Electrodes