QUELL

GUDID 00851221006049

QUELL Sport Electrode

NEUROMETRIX, INC.

Electrode conductive medium

• Primary Device ID: 00851221006049
• NIH Device Record Key: 096495fe-5deb-4406-b11d-7a5d8184bca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUELL
• Version Model Number: QE-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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 781-314-2781
• Email: rainer_maas@neurometrix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006049 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2017-03-07

On-Brand Devices [QUELL]

• 10851221006435: Amazon Quell Device Box (includes device, 1 electrode with UDI 00851221006018 or UDI 00851221006
• 00851221006414: FSA Store Quell Device Box (includes device, 1 electrode with UDI 00851221006018, 1 electrode wi
• 00851221006377: Retailer Quell Club Device Box (includes device, 3 electrodes with UDI 00851221006018, 1 charger
• 00851221006070: HCP Starter Kit (includes device, 1 pack electrode with UDI 00851221006018, 1 charger, 1 charger
• 00851221006049: QUELL Sport Electrode
• 20851221006036: Quell Electrodes Retail - 1 Month supply (1 pack electrodes with UDI 00851221006018 or UDI 00851
• 00851221006025: Retailer Quell Device Box (includes device, 1 electrode with UDI 00851221006018 or UDI 008512210
• 00851221006018: QUELL Electrode
• 00851221006001: Consumer Starter Kit (includes device, 1 pack electrode with UDI 00851221006018, 1 charger, 1 ch