FDA-Device2023-12-13Class II

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

Liberty Medical Solutions, LLC
Hazard

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.

Sold states
US Nationwide distribution in the states of CT, FL, NC, NJ, NY.
Affected count
473 units
Manufactured in
3653 Madaca Ln, Tampa, FL, United States
Products
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2024

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