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LIFEWARD LTD · Model 50-40-0001 · UDI-DI 00860001744507

PHL Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.

Recalls

Date	Firm	Reason
2025-04-03	WANDERCRAFT SAS	Potential for exoskeleton to lose lateral balance and cause patient to fall.
2020-02-28	Argo Medical Technologies Ltd	ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caug
2017-08-14	Argo Medical Technologies Ltd	Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.

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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.