InterX - A dynamically different clinical application for - Interx Technologies

Duns Number:056903080

Device Description: A dynamically different clinical application for the effective treatment of pain and injur 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.

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More Product Details

Catalog Number

1141-001

Brand Name

InterX

Version/Model Number

5002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042912

Product Code Details

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

4b2eff92-935e-4295-8127-27e976f3a27f

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTERX TECHNOLOGIES" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16