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InterX

HTK ENTERPRISES, INC. · Model 1000 · UDI-DI 00851894007022

GZJ Prescription

510(k) clearances

507

Adverse events (4 deaths)

Recalls

188

Facilities

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.

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.