DPNCheck 2.0

GUDID 00851221006056

DPNCheck 2.0 Device

NeuroMetrix, Inc.

Diagnostic peripheral nerve electrical stimulation system

• Primary Device ID: 00851221006056
• NIH Device Record Key: e70218fd-c477-4404-a01e-7cfe4e8783fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DPNCheck 2.0
• Version Model Number: NC-040
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 781-314-2706
• Email: Mike_Dulude@neurometrix.com
• Phone: 781-314-2706
• Email: Mike_Dulude@neurometrix.com
• Phone: 781-314-2706
• Email: Mike_Dulude@neurometrix.com
• Phone: 781-314-2706
• Email: Mike_Dulude@neurometrix.com
• Phone: 781-314-2706
• Email: Mike_Dulude@neurometrix.com
• Phone: 781-314-2706
• Email: Mike_Dulude@neurometrix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851221006056 [Primary]

FDA Product Code

• JXE: Device, Nerve Conduction Velocity Measurement

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: 2026-01-12
• Device Publish Date: 2022-12-20

Devices Manufactured by NeuroMetrix, Inc.

• 00851221006056 - DPNCheck 2.0: 2026-01-12DPNCheck 2.0 Device
• 00851221006056 - DPNCheck 2.0: 2026-01-12 DPNCheck 2.0 Device
• 00851221006575 - DPNCheck, China: 2026-01-12 DPNCheck Device, China
• 00851221006582 - DPNCheck, Japan: 2026-01-12 DPNCheck Device, Japan
• 00851221006513 - Quell Fibromyalgia: 2025-08-11 Standard Band for 2.0 Device
• 00851221006520 - Quell Fibromyalgia: 2025-08-11 Quell 12-Month Electrode Kit (Regular) - 12 sleeves of Electrodes
• 00851221006551 - Quell Fibromyalgia: 2025-08-11 Quell 12-Month Electrode Kit (Sport)
• 00851221006704 - Quell: 2025-08-11 Extension Band
• 00851221006735 - Quell 2.0: 2025-08-11 Small Band for 2.0 Device