InterX

Basic Information

• Brand Name: InterX
• Primary DI: 00851894007244
• Version / Model: 1507
• Catalog Number: 1507-001
• Company Name: Interx Technologies
• Labeler DUNS: 056903080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: fabce343-ab46-40a4-91a5-6ed0edebedb7

Device Description

The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. The InterX Personal Flexible Array can be connected to the InterX 900 Device via this Y-Cable. It is designed to provide 20 minutes of treatment options and can be used unattended once treatment parameters have been set on the InterX 900 device or dynamically for muscle re-education. This Y-Cable along with the InterX Personal Flexible Array is indicated for symptomatic relief and management of chronic intractable pain and also adjunctive treatment in the management of post-surgical and post traumatic pain.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851894007244	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	58	Gram
Length	98.7	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius