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InterX

HTK ENTERPRISES, INC. · Model 5002 · UDI-DI 00851894007015

GZJ Prescription

510(k) clearances

503

Adverse events (4 deaths)

Recalls

186

Facilities

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.

Recalls

Date	Firm	Reason
2011-02-07	Neuro Resource Group Inc	Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
2008-07-18	Synaptic Corp	Device was distributed without marketing approval.
2007-06-29	Avazzia, Inc	Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29	Avazzia, Inc	Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29	Avazzia, Inc	Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
2007-06-29	Avazzia, Inc	Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
2003-05-23	Rehabilicare	If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.