FDA Device Intelligence
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Stimulator, Neuromuscular, External Functional

FDA product code GZI · Class 2 · Neurology

251
Registered devices
50
Adverse events
2
Recalls
61
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-07-19Myolyn Inc.Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
2008-08-06Innovative Neurotronics, Inc.Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.