Stimulator, Muscle, Powered

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

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.

IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode.

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.

Perfector

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

Ion Magnum

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

Arasys

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

eSwallow Multi-Program Dysphagia Therapy Test unit

It was discovered that the firm was distributing medical devices without FDA approval.

The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes),

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 the lithium battery to swell around two years of use and it causes the device to be inoperable.