QUELL FIBROMYALGIA

GUDID 00851221006636

Quell Healthwarehouse Bundle - 3 Sport Electrode packs and 1 Standard Quell Band (3 pack sport electrodes with UDI 00851221006049 and 1 Quell Band with UDI 00851221006513 in poly bag)

NEUROMETRIX, INC.

Electrode conductive medium

• Primary Device ID: 00851221006636
• NIH Device Record Key: a72b8844-7ea4-4418-83a0-bab370bc5c94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUELL FIBROMYALGIA
• Version Model Number: QE-HWB-P02
• Company DUNS: 957536014
• Company Name: NEUROMETRIX, INC.
• 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: 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: 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
• Phone: 17813142706
• Email: Mike_Dulude@neurometrix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006636 [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: 2023-03-14
• Device Publish Date: 2023-03-06

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
• 00851221006407: Prescription 120 Day Starter Kit (includes 1 device, 4 packs of electrodes with UDI 008512210060
• 00851221006810: Quell 2.0 Fibromyalgia Replacement Device (RX)
• 00851221006551: Quell 12-Month Electrode Kit (Sport)
• 00851221006520: Quell 12-Month Electrode Kit (Regular) - 12 sleeves of Electrodes
• 00851221006513: Standard Band for 2.0 Device