InterX

Basic Information

• Brand Name: InterX
• Primary DI: 00851894007336
• Version / Model: 200
• Catalog Number: 1075-001
• 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: 19a925cf-d5b0-4067-a41c-ac83e10637c9

Device Description

The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. Electrode accessories can be connected to InterX Devices to deliver enhanced treatment as well as dynamic and unattended treatment. The Cosmetic Electrode Accessory is compatible with both the InterX 5002 and InterX 1000 devices. The Cosmetic Electrode Accessory is primarily used as a facial treatment.

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
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	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	00851894007336	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070217	000

Device Sizes

Type	Value	Unit	Text
Weight	72.0	Gram
Length	110.5	Centimeter

Storage Conditions

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