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