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InterX

HTK ENTERPRISES, INC. · Model Professional Sport · UDI-DI 00851894007008

GZJ Prescription

510(k) clearances

507

Adverse events (4 deaths)

Recalls

188

Facilities

Description

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.

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.