InterX
Basic Information
- Brand Name
- InterX
- Primary DI
- 00851894007008
- Version / Model
- Professional Sport
- Catalog Number
- 1140-001
- Company Name
- Interx Technologies
- Labeler DUNS
- 056903080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 8
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 21c04fa4-8284-44af-9336-1852519969ba
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851894007008 | GS1 |
Customer Contacts
- Phone
- 972-665-1810
- [email protected]
- Phone
- 469-364-3420
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042912 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 45 | Millimeter | |
| Width | 63 | Millimeter | |
| Length | 220 | Millimeter | |
| Weight | 330 | Gram |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- If condensation occurs, allow 3 hour equalization at room temperature.
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius