InterX

Basic Information

Brand Name: InterX
Primary DI: 00851894007015
Version / Model: 5002
Catalog Number: 1141-001
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: 4b2eff92-935e-4295-8127-27e976f3a27f

Device Description

A dynamically different clinical application for the effective treatment of pain and injury, the InterX® 5002 is a non-invasive Interactive Neurostimulation device which uses a high amplitude, high density stimulation. When applied to the cutaneous nerves it activates the body’s natural pain relieving mechanisms releasing multiple neuropeptides. The graphical display provides users with quick and easy access to preset stimulation patterns for acute and chronic conditions, as well as treatment cycle programs to treat a full range of injuries and conditions. The InterX® 5002 has an additional 'activity reading' feature that uses advanced numerical readings to objectively indentify optimal treatment points, helping to ensure the most effective targeted treatment which in chronic conditions is frequently away from the area of pain. This enhances treatment outcomes and shortens recovery time. The InterX® 5002, with its unique interactive stimulation provides highly effective, non-invasive, non-drug pain relief with simple treatment applications. Lightweight, portable, and battery operated, the InterX® 5002 is the perfect solution for pain and rehabilitation specialists everywhere.

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	00851894007015	GS1

Customer Contacts

Phone: 972-665-1810
Email: [email protected]
Phone: 469-364-3420
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K042912	000

Device Sizes

Type	Value	Unit
Height	45	Millimeter
Width	63	Millimeter
Length	220	Millimeter
Weight	330	Gram

Storage Conditions

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
Type: Special Storage Condition, Specify
Special Conditions: If condensation occurs, allow 3 hour equalization at room temperature.