Identity
- Trade Name
- InterX FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- 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. All Electrode Accessories are compatible with both the InterX 5002 and InterX 1000 devices. The Comb Electrode Accessory is used for the scalp and where hair may interfere with electrode skin contact. FDA UDI
- Model / Reference
- 300 FDA UDI
- 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. All Electrode Accessories are compatible with both the InterX 5002 and InterX 1000 devices. The Comb Electrode Accessory is used for the scalp and where hair may interfere with electrode skin contact. FDA UDI
Identifiers
- Catalog Number
- 1070-001 FDA UDI
- Primary DI / UDI-DI
- 00851894007114 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 77.8 Gram FDA UDILength — 108 Centimeter FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
InterX by Htk Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Htk Enterprises, Inc.
Sources (1)
- FDA UDI da0e798c-21ff-43f7-9381-fab7d656a135 37 fields · synced May 30, 2026