Duns Number:056903080
Device Description: The InterX® Personal Sport provides you with a simple non-drug option for the pain related The InterX® Personal Sport provides you with a simple non-drug option for the pain related to acute or chronic injuries. Treatment can be prescribed independently or used in conjunction with other therapies to manage injuries through the recovery process. Available to individuals as a home use product or as a support during treatment with the InterX® Professional Sport model, the InterX® Personal Sport provides simple and effective treatment applications for sports and acute injuries, minor aches and pains, sprains and strains, non-complex chronic pain, general back, shoulder, and neck conditions, aggravated joint pain, muscle spasm, and hematoma (bruising/swelling).
Catalog Number
1150-001
Brand Name
InterX
Version/Model Number
Personal 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
43cf1157-52eb-45ef-9197-251fed6c52f5
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 |