MyndStep

MyndTec Inc · Model MyndStep Foot Drop Stimulator · UDI-DI 00692520001027

GZI IPF Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

MyndStep is a wearable foot drop device, which comprises by stimulator unit, MyndStep APP, electrode lead wire, electrodes and leg brace. It can control the timing and duration of the stimulation by tracing the angle during walking. It uses FES (functional electrical stimulation) to treat and improve the patient's foot drop to help the patient improve their walking ability.

Recalls

Date	Firm	Reason
2022-07-19	Myolyn Inc.	Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
2008-08-06	Innovative 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.