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.
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
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
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |