InterX

Basic Information

• Brand Name: InterX
• Primary DI: 00851894007046
• Version / Model: 900
• Catalog Number: 1478-001
• Company Name: Interx Technologies
• Labeler DUNS: 056903080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 8
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: fca16d46-a27e-434a-af13-cae7198ec43c

Device Description

The InterX® 900 Single Patient Systems are the latest addition to the InterX family and have been designed with ease of use in mind. The same unique InterX Neurostimulation is delivered through self-adhesive disposable dual electrodes and through body specific conductive garments which are attached to relevant parts of the body. Built in preset stimulation patterns deliver a range of high and low frequency stimulation to optimize the effects of treatment and assist the patient in returning to full function.

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	00851894007046	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042912	000

Device Sizes

Type	Value	Unit	Text
Weight	185	Gram
Height	43	Millimeter
Width	52	Millimeter
Length	215	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: If condensation occurs, allow 3 hour equalization at room temperature.
• Type: Storage Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius