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InterX

HTK ENTERPRISES, INC. · Model 900 · UDI-DI 00851894007046

GZJ Prescription

510(k) clearances

507

Adverse events (4 deaths)

Recalls

185

Facilities

Description

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.

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.