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WalkAide Unit

INNOVATIVE NEUROTRONICS, INC. · Model 20-0100 · UDI-DI 00858184006000

GZI Prescription
1
510(k) clearances
50
Adverse events (1 deaths)
2
Recalls
41
Facilities

Description

The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.

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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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.