QUELL FIBROMYALGIA

GUDID 00851221006681

Quell Standard Electrode Bundle for Government Markets (3 Standard Quell Electrode packs with UDI 00851221006018 and 1 Quell Band with UDI 00851221006513 in poly bag)

NEUROMETRIX, INC.

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• Primary Device ID: 00851221006681
• NIH Device Record Key: f87b43da-e96f-4243-b17a-307e57159234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUELL FIBROMYALGIA
• Version Model Number: QE-ELG-P01
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006681 [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: 2023-11-30
• Device Publish Date: 2023-11-22

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