FDA UDI In Commercial Distribution 🇺🇸 United States

InterX

DI: 00851894007411 · Model: InterX XPad · HTK ENTERPRISES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
InterX
Primary DI
00851894007411
Version / Model
InterX XPad
Catalog Number
1750-001
Company Name
HTK ENTERPRISES, INC.
Labeler DUNS
056903080
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-21
Public Version
1
Public Version Date
2026-04-29
Public Version Status
New
Public Device Record Key
f93c03e8-a1d1-4f54-80f0-0cdac813c504

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 XPad Electrode 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 XPad Electrode 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
GXY Electrode, Cutaneous

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 00851894007411

Customer Contacts

Phone
972-665-1810
Phone
469-364-3420

Device Sizes

Type Value Unit Text
Weight 20.0 Gram
Length 19.05 Centimeter

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
15 – 40 Degrees Celsius