← Back to catalogue

InterX

FDA UDI

Class II (US FDA UDI)

by Htk Enterprises, Inc.

Identity

Trade Name
InterX FDA UDI
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name
The InterX® 1000 is designed to provide personal treatment at home of painful conditions or general stiffness. The InterX® 1000 can be prescribed independently, or used in conjunction with other therapies or as a support to treatment with the InterX professional models. The InterX® 1000 provides an interactive response to the body’s changes during recovery from injury, surgery or general healing. When applied to the skin, electrical impulses adjust dynamically through the various electrodes as the device encounters changes in the skin as the body begins to heal. This interactive capability not only provides results, but also resists the body’s natural tendency to develop a tolerance to static therapies. It’s conveniently designed with 5 preset stimulation patterns and easily attached accessories to treat the face, scalp, spine and extremities. Being battery operated and completely portable, the InterX® 1000 is a pain management device suitable for individuals everywhere. FDA UDI
Model / Reference
1000 FDA UDI
Description
The InterX® 1000 is designed to provide personal treatment at home of painful conditions or general stiffness. The InterX® 1000 can be prescribed independently, or used in conjunction with other therapies or as a support to treatment with the InterX professional models. The InterX® 1000 provides an interactive response to the body’s changes during recovery from injury, surgery or general healing. When applied to the skin, electrical impulses adjust dynamically through the various electrodes as the device encounters changes in the skin as the body begins to heal. This interactive capability not only provides results, but also resists the body’s natural tendency to develop a tolerance to static therapies. It’s conveniently designed with 5 preset stimulation patterns and easily attached accessories to treat the face, scalp, spine and extremities. Being battery operated and completely portable, the InterX® 1000 is a pain management device suitable for individuals everywhere. FDA UDI

Identifiers

Catalog Number
1149-001 FDA UDI
Primary DI / UDI-DI
00851894007022 FDA UDI
510(k) Number
K042912 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

No

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 — 185 Gram FDA UDI
Height — 43 Millimeter FDA UDI
Width — 52 Millimeter FDA UDI
Length — 215 Millimeter 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

Similar devices

Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.

Cleared under the same submission

K042912 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Htk Enterprises, Inc.

Sources (1)

  • FDA UDI 6b0c7cf4-7c62-4c8b-bc07-da18e2cfdd3e 38 fields · synced May 31, 2026