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InterX

HTK ENTERPRISES, INC. · Model 1589 · UDI-DI 00851894007343

GXY Prescription

510(k) clearances

530

Adverse events (1 deaths)

Recalls

252

Facilities

Description

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.

Recalls

Date	Firm	Reason
2023-10-02	Coapt LLC	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
2023-10-02	Coapt LLC	Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-03-14	Neuralynx Inc	Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufa
2014-04-24	Medtronic Navigation, Inc.	Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriate
2014-04-24	Medtronic Navigation, Inc.	Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriate
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the
2012-02-09	Covidien LLC dba Uni-Patch	Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in the

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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.