InterX - The InterX® 1000 is designed to provide personal - Interx Technologies

Duns Number:056903080

Device Description: The InterX® 1000 is designed to provide personal treatment at home of painful conditions o 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.

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More Product Details

Catalog Number

1149-001

Brand Name

InterX

Version/Model Number

1000

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

6b0c7cf4-7c62-4c8b-bc07-da18e2cfdd3e

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