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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
A dynamically different clinical application for the effective treatment of pain and injury, the InterX® 5002 is a non-invasive Interactive Neurostimulation device which uses a high amplitude, high density stimulation. When applied to the cutaneous nerves it activates the body’s natural pain relieving mechanisms releasing multiple neuropeptides. The graphical display provides users with quick and easy access to preset stimulation patterns for acute and chronic conditions, as well as treatment cycle programs to treat a full range of injuries and conditions. The InterX® 5002 has an additional 'activity reading' feature that uses advanced numerical readings to objectively indentify optimal treatment points, helping to ensure the most effective targeted treatment which in chronic conditions is frequently away from the area of pain. This enhances treatment outcomes and shortens recovery time. The InterX® 5002, with its unique interactive stimulation provides highly effective, non-invasive, non-drug pain relief with simple treatment applications. Lightweight, portable, and battery operated, the InterX® 5002 is the perfect solution for pain and rehabilitation specialists everywhere. FDA UDI
Model / Reference
5002 FDA UDI
Description
A dynamically different clinical application for the effective treatment of pain and injury, the InterX® 5002 is a non-invasive Interactive Neurostimulation device which uses a high amplitude, high density stimulation. When applied to the cutaneous nerves it activates the body’s natural pain relieving mechanisms releasing multiple neuropeptides. The graphical display provides users with quick and easy access to preset stimulation patterns for acute and chronic conditions, as well as treatment cycle programs to treat a full range of injuries and conditions. The InterX® 5002 has an additional 'activity reading' feature that uses advanced numerical readings to objectively indentify optimal treatment points, helping to ensure the most effective targeted treatment which in chronic conditions is frequently away from the area of pain. This enhances treatment outcomes and shortens recovery time. The InterX® 5002, with its unique interactive stimulation provides highly effective, non-invasive, non-drug pain relief with simple treatment applications. Lightweight, portable, and battery operated, the InterX® 5002 is the perfect solution for pain and rehabilitation specialists everywhere. FDA UDI

Identifiers

Catalog Number
1141-001 FDA UDI
Primary DI / UDI-DI
00851894007015 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
Height — 45 Millimeter FDA UDI
Width — 63 Millimeter FDA UDI
Length — 220 Millimeter FDA UDI
Weight — 330 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

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

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Manufacturer

Manufacturer
Htk Enterprises, Inc.

Sources (1)

  • FDA UDI 4b2eff92-935e-4295-8127-27e976f3a27f 38 fields · synced May 30, 2026