InterX

Basic Information

• Brand Name: InterX
• Primary DI: 00851894007138
• Version / Model: 500
• Catalog Number: 1155-001
• 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: 22fa76b3-782c-4b72-8788-add725209f89

Device Description

The InterX 4x4 Flexible Array Electrode is designed to provide 10 minute treatment options and can be used unattended once treatment parameters have been set on the InterX 5002 or InterX 1000 devices. The InterX 4x4 Flexible Array Electrode Accessory can be used for the spine, hamstring, and quad for unattended treatment or dynamically for muscle re-education. Indications for use: Symptomatic relief and management of chronic intractable pain; Adjunctive treatment in the management of post-surgical and post-traumatic pain; Relaxing muscle spasms.

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
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	00851894007138	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053626	000

Device Sizes

Type	Value	Unit	Text
Length	111.76	Centimeter
Weight	163.6	Gram

Storage Conditions

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