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Omnistim FX2 Pro Sport

ACCELERATED CARE PLUS CORP · Model 100FX2D · UDI-DI 00858703006030

IPF Prescription

510(k) clearances

678

Adverse events (1 deaths)

Recalls

179

Facilities

Description

The Omnistim® FX2 Pro provides Patterned Electrical Neuromuscular Stimulation (PENS), which is a form of stimulation that replicates the correct firing patterns of muscles (agonist and antagonist or reciprocal muscle pairs) in triphasic (ballistic), biphasic (reciprocal), or functional patterns. This approach to neuro re-ed provides a high intensity, precisely timed sensory input, which duplicates the firing activity of sensory neurons and muscle stretch receptors during voluntary activity.

Recalls

Date	Firm	Reason
2023-11-03	Liberty Medical Solutions, LLC	The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2012-01-06	Ion Genius, Inc.	Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
2011-06-22	eSwallow USA LLC	It was discovered that the firm was distributing medical devices without FDA approval.
2009-01-25	Zynex Medical, Inc.	Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
2008-06-11	International Rehabilitative Sciences, Inc.	The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes

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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.