Omnistim 500 Pro
ACCELERATED CARE PLUS CORP · Model 100500C · UDI-DI 00858703006016
Description
The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC), Medium Frequency Alternating Currents (MFAC), Low Voltage Pulsed Current (LVPC) and High Voltage Pulsed Current Therapy (HVPC). Its two separate generators produce medium frequency (2000, 2500, 4000 or 5000 Hz) alternating current in continuous or modulated modes. Two isolated output circuits with independent intensity controls are provided. The Omnistim® 500 Pro MFAC and LVPC modes with fully adjustable ON and OFF times and ON and OFF ramps provides a wide variety of uses for muscle re-education and muscle spasm reduction protocols for innervated muscle. The Omnistim® 500 Pro provides High Voltage Pulsed Current (HVPC) on one channel. Continuous or surged operation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Increasing circulation, pain control and muscle re-ed can be set up in this mode.
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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