Identity
- Trade Name
- InterX FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- The InterX 3x3 Dual Flexible Array Electrode is designed to provide 10 minute treatment options and can be used unattended once treatment parameters have been set on the InterX 5002 or InterX 1000 devices. The InterX 3x3 Dual Flexible Array Electrode Accessory can be used on the neck, spine, joints, and extremities for unattended treatment or dynamically for muscle re-eductaion. Indications for use: Symptomatic relief and management of chronic intractable pain; Adjunctive treatment in the management of post-surgical and post-traumatic pain; Relaxing muscle spasms. FDA UDI
- Model / Reference
- 533 FDA UDI
- Description
- The InterX 3x3 Dual Flexible Array Electrode is designed to provide 10 minute treatment options and can be used unattended once treatment parameters have been set on the InterX 5002 or InterX 1000 devices. The InterX 3x3 Dual Flexible Array Electrode Accessory can be used on the neck, spine, joints, and extremities for unattended treatment or dynamically for muscle re-eductaion. Indications for use: Symptomatic relief and management of chronic intractable pain; Adjunctive treatment in the management of post-surgical and post-traumatic pain; Relaxing muscle spasms. FDA UDI
Identifiers
- Catalog Number
- 1220-001 FDA UDI
- Primary DI / UDI-DI
- 00851894007145 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
- Length — 113 Centimeter FDA UDIWeight — 195.6 Gram 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 38c38496-16a3-4e08-854c-83f3b6aecb9c 37 fields · synced Jun 6, 2026