FDA.reportPublic FDA data

HTK ENTERPRISES, INC.

GUDID#

InterX - 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.

HTK ENTERPRISES, INC.

2026-04-21

InterX - The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. The InterX XPad Electrode can be connected to both the InterX 1000 and InterX 5002 Devices via this Y-Cable. The InterX XPad Electrode is intended for single patient use. Both the InterX 1000 and InterX 5002 devices are designed to provide 10 minutes of treatment options and can be used unattended once treatment parameters have been set on either the InterX 1000 or InterX 5002 device or dynamically for muscle re-education. This Y-Cable along with the InterX XPad 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.

HTK ENTERPRISES, INC.

2026-04-21

InterX - 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.

HTK ENTERPRISES, INC.

2025-05-09

InterX - The InterX 4x4 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 4x4 Flexible Array Electrode Accessory can be used for the spine, hamstring, and quad for unattended treatment or dynamically for muscle re-education. 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.

HTK ENTERPRISES, INC.

2020-06-01

InterX - 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.

HTK ENTERPRISES, INC.

2020-06-01

InterX - 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. All Electrode Accessories are compatible with both the InterX 5002 and InterX 1000 devices. The Universal Classic Electrode Accessory is used for scanning the face, hand, wrist, toes, and ankles. The Classic Accessory is made for small treatment areas, giving better skin contact.

HTK ENTERPRISES, INC.

2020-06-01

InterX - 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. All Electrode Accessories are compatible with both the InterX 5002 and InterX 1000 devices. The Universal Soft Tissue Electrode Accessory is used for soft tissue manipulation and as a massage for fascia restrictions and scar management.

HTK ENTERPRISES, INC.

2020-06-01

InterX - 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. All Electrode Accessories are compatible with both the InterX 5002 and InterX 1000 devices. The Dome Electrode Accessory is used for large surface areas and concentrated treatment for dynamic applications and unattended use.

HTK ENTERPRISES, INC.

2020-06-01

InterX - The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. The InterX Personal Flexible Array can be connected to the InterX 900 Device via this Y-Cable. It is designed to provide 20 minutes of treatment options and can be used unattended once treatment parameters have been set on the InterX 900 device or dynamically for muscle re-education. This Y-Cable along with the InterX Personal Flexible Array 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.

HTK ENTERPRISES, INC.

2020-06-01

InterX - 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 Personal Flexible Array is compatible with both the InterX 5002 and InterX 1000 devices. It is designed to provide 10 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 Personal Flexible 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.

HTK ENTERPRISES, INC.

2020-06-01

InterX - The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. The InterX Personal Flexible Array can be connected to both the InterX 1000 and InterX 5002 Devices via this Y-Cable. The InterX Personal Flexible Array is intended for single patient use. Both the InterX 1000 and InterX 5002 devices are designed to provide 10 minutes of treatment options and can be used unattended once treatment parameters have been set on either the InterX 1000 or InterX 5002 device or dynamically for muscle re-education. This Y-Cable along with the InterX Personal Flexible Array 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.

HTK ENTERPRISES, INC.

2020-06-01

InterX - The InterX® Professional Sport is designed specifically for sports medicine professionals. Interactive technology is combined with a user interface providing immediate access to preset stimulation patterns for a range of sports and related injuries. The injury curve is represented with a graphical display. Each stage of injury from onset to recovery has an optimal treatment setting, with a short list of further stimulation patterns that are relevant to that stage of injury. The InterX® Professional Sport with its unique interactive stimulation provides highly effective, non-invasive, non-drug pain relief with simple treatment applications. Fully portable and battery operated, the InterX® Sport is the perfect solution to effective and simple pain and injury management for sports medicine professionals everywhere.

HTK ENTERPRISES, INC.

2016-09-24

InterX - 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.

HTK ENTERPRISES, INC.

2016-09-24

InterX - 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.

HTK ENTERPRISES, INC.

2016-09-24

InterX - The InterX® Personal Sport provides you with a simple non-drug option for the pain related to acute or chronic injuries. Treatment can be prescribed independently or used in conjunction with other therapies to manage injuries through the recovery process. Available to individuals as a home use product or as a support during treatment with the InterX® Professional Sport model, the InterX® Personal Sport provides simple and effective treatment applications for sports and acute injuries, minor aches and pains, sprains and strains, non-complex chronic pain, general back, shoulder, and neck conditions, aggravated joint pain, muscle spasm, and hematoma (bruising/swelling).

HTK ENTERPRISES, INC.

2016-09-24

InterX - The InterX® 900 Single Patient Systems are the latest addition to the InterX family and have been designed with ease of use in mind. The same unique InterX Neurostimulation is delivered through self-adhesive disposable dual electrodes and through body specific conductive garments which are attached to relevant parts of the body. Built in preset stimulation patterns deliver a range of high and low frequency stimulation to optimize the effects of treatment and assist the patient in returning to full function.

HTK ENTERPRISES, INC.

2016-09-24