InterX - The InterX® Professional Sport is designed - Interx Technologies

Duns Number:056903080

Device Description: The InterX® Professional Sport is designed specifically for sports medicine professionals. The InterX® Professional Sport is designed specifically for sports medicine professionals. Interactive technology is combined with a user interface providing immediate access to preset stimulation patterns for a range of sports and related injuries. The injury curve is represented with a graphical display. Each stage of injury from onset to recovery has an optimal treatment setting, with a short list of further stimulation patterns that are relevant to that stage of injury. The InterX® Professional Sport with its unique interactive stimulation provides highly effective, non-invasive, non-drug pain relief with simple treatment applications. Fully portable and battery operated, the InterX® Sport is the perfect solution to effective and simple pain and injury management for sports medicine professionals everywhere.

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More Product Details

Catalog Number

1140-001

Brand Name

InterX

Version/Model Number

Professional Sport

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

21c04fa4-8284-44af-9336-1852519969ba

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