Duns Number:056903080
Device Description: The InterX 4x4 Flexible Array Electrode is designed to provide 10 minute treatment options The InterX 4x4 Flexible Array Electrode is designed to provide 10 minute treatment options and can be used unattended once treatment parameters have been set on the InterX 5002 or InterX 1000 devices. The InterX 4x4 Flexible Array Electrode Accessory can be used for the spine, hamstring, and quad for unattended treatment or dynamically for muscle re-education. Indications for use: Symptomatic relief and management of chronic intractable pain; Adjunctive treatment in the management of post-surgical and post-traumatic pain; Relaxing muscle spasms.
Catalog Number
1155-001
Brand Name
InterX
Version/Model Number
500
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
K053626
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
22fa76b3-782c-4b72-8788-add725209f89
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
June 01, 2020
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 |