QUELL 2.0

GUDID 00851221006483

Amazon Quell 2.0 Device Box (includes device, 1 electrode with UDI 00851221006018 and/or UDI 00851221006049, 1 charger, 1 charger cable, 1 sport band)

NEUROMETRIX, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00851221006483
• NIH Device Record Key: 26a266ef-826f-4377-8509-716ab77c2358
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUELL 2.0
• Version Model Number: QE-NAZ
• 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: 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: 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 -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006483 [Primary]

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-09-17

On-Brand Devices [QUELL 2.0]

• 00851221006483: Amazon Quell 2.0 Device Box (includes device, 1 electrode with UDI 00851221006018 and/or UDI 008
• 00851221006469: Consumer Starter Kit, eCommerce (includes device, 1 pack electrode with UDI 00851221006018, 1 ch
• 00851221006452: Retailer Quell 2.0 Device Box (includes device, 1 electrode with UDI 00851221006018 or UDI 00851