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. The InterX Comfort Flex III Array is compatible with both the InterX 5002 and InterX 1000 devices. It is designed to provide 10 to 20 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 Comfort Flex III 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. FDA UDI
- Model / Reference
- 1675 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. The InterX Comfort Flex III Array is compatible with both the InterX 5002 and InterX 1000 devices. It is designed to provide 10 to 20 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 Comfort Flex III 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. FDA UDI
Identifiers
- Catalog Number
- 1675-001 FDA UDI
- Primary DI / UDI-DI
- 00851894007367 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 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 — 20.0 Gram FDA UDILength — 23.5 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 4a63df74-e8d4-491b-88a0-829218b48efb 37 fields · synced Jun 6, 2026