InterX

Basic Information

Brand Name: InterX
Primary DI: 00851894007022
Version / Model: 1000
Catalog Number: 1149-001
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: 6b0c7cf4-7c62-4c8b-bc07-da18e2cfdd3e

Device Description

The InterX® 1000 is designed to provide personal treatment at home of painful conditions or general stiffness. The InterX® 1000 can be prescribed independently, or used in conjunction with other therapies or as a support to treatment with the InterX professional models. The InterX® 1000 provides an interactive response to the body’s changes during recovery from injury, surgery or general healing. When applied to the skin, electrical impulses adjust dynamically through the various electrodes as the device encounters changes in the skin as the body begins to heal. This interactive capability not only provides results, but also resists the body’s natural tendency to develop a tolerance to static therapies. It’s conveniently designed with 5 preset stimulation patterns and easily attached accessories to treat the face, scalp, spine and extremities. Being battery operated and completely portable, the InterX® 1000 is a pain management device suitable for individuals 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	00851894007022	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
Weight	185	Gram
Height	43	Millimeter
Width	52	Millimeter
Length	215	Millimeter

Storage Conditions

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