DPNCheck

Basic Information

• Brand Name: DPNCheck
• Primary DI: 00816022023671
• Version / Model: NC-040-C
• Company Name: IMPULSE MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 080015502
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-09
• Public Version: 1
• Public Version Date: 2026-01-19
• Public Version Status: New
• Public Device Record Key: 7d2a9924-49b9-4eac-8d60-c4dbd8f6c65f

Device Description

DPNCheck 2.0 Device - China (for sale in Chinese market)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	882.1550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35729	Diagnostic peripheral nerve electrical stimulation system	An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816022023671	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K041320	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 55 – 100 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius