QUELL

GUDID 00851221006070

HCP Starter Kit (includes device, 1 pack electrode with UDI 00851221006018, 1 charger, 1 charger cable, 1 sport band)

NEUROMETRIX, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00851221006070
• NIH Device Record Key: 78f3555a-99a2-46e6-bd03-a5b09608b078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUELL
• Version Model Number: QE-SYP
• 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	00851221006070 [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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-08

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