InterX
Basic Information
- Brand Name
- InterX
- Primary DI
- 00851894007251
- Version / Model
- 1475
- Catalog Number
- 1475-001
- Company Name
- Interx Technologies
- Labeler DUNS
- 056903080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-01
- Public Version
- 4
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 70c3aafc-2366-4bef-bf5a-30d1ccbdd934
Device Description
The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. Electrode accessories can be connected to InterX Devices to deliver enhanced treatment as well as dynamic and unattended treatment. The InterX Personal Flexible Array is compatible with both the InterX 5002 and InterX 1000 devices. It is designed to provide 10 minutes of treatment options and can be used unattended once treatment parameters have been set on the InterX device or dynamically for muscle re-education. The InterX Personal Flexible Array is intended for single patient use. This Accessory Electrode is indicated for symptomatic relief and management of chronic intractable pain and also adjunctive treatment in the management of post-surgical and post traumatic pain.
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
- Yes
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 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 | 00851894007251 | GS1 |
Customer Contacts
- Phone
- 972-665-1810
- [email protected]
- Phone
- 469-364-3420
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 20.0 | Gram | |
| Length | 23.5 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius