Duns Number:056903080
Device Description: The InterX® 900 Single Patient Systems are the latest addition to the InterX family and ha The InterX® 900 Single Patient Systems are the latest addition to the InterX family and have been designed with ease of use in mind. The same unique InterX Neurostimulation is delivered through self-adhesive disposable dual electrodes and through body specific conductive garments which are attached to relevant parts of the body. Built in preset stimulation patterns deliver a range of high and low frequency stimulation to optimize the effects of treatment and assist the patient in returning to full function.
Catalog Number
1478-001
Brand Name
InterX
Version/Model Number
900
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
fca16d46-a27e-434a-af13-cae7198ec43c
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 |