RehaStim 2

HASOMED GmbH · Model FES01090 · UDI-DI 04260397620342

GZI Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.

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.