InterX
Basic Information
- Brand Name
- InterX
- Primary DI
- 00851894007343
- Version / Model
- 1589
- Catalog Number
- 1589-001
- 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
- c8aa4e81-c34e-4fdf-aff3-870905f18f88
Device Description
The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. The InterX Personal Flexible Array can be connected to both the InterX 1000 and InterX 5002 Devices via this Y-Cable. The InterX Personal Flexible Array is intended for single patient use. Both the InterX 1000 and InterX 5002 devices are designed to provide 10 minutes of treatment options and can be used unattended once treatment parameters have been set on either the InterX 1000 or InterX 5002 device or dynamically for muscle re-education. This Y-Cable along with the InterX Personal Flexible Array 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 | 00851894007343 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 58.0 | Gram | |
| Length | 98.7 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius