FDA Device Intelligence
Home › LIFEWARD LTD › ReWalk 7 Personal Exoskeleton

ReWalk 7 Personal Exoskeleton

LIFEWARD LTD · Model ReWalk 7 · UDI-DI 00860001744514

PHL Prescription
10
510(k) clearances
57
Adverse events
3
Recalls
8
Facilities

Description

The ReWalk 7 Personal Exoskeleton is a wearable, battery-powered prescription device intended for use by certified individuals at least 18 years old with lower limb disability to perform routine ambulatory functions at home and in the community. Control of the exoskeleton is achieved through a user-worn wireless, web connected wrist control unit (WCU), a wireless crutch-mounted control unit (CCU), and specific body movements as measured through a tilt sensor. The powered device movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk 7 Personal Exoskeleton includes the exoskeleton (incl. rigid frames, waist pack, and straps), battery power supply, crutches with integrated powered crutch control add-on unit (CCU), and the Wrist Control Unit (WCU). The wireless, web connected therapist handheld device (THD) is used by certified therapists for device configuration and control. All ReWalk 7 Personal Exoskeleton components are suitable for indoor and outdoor use. The ReWalk use includes standing, walking on level surfaces, mild slopes, ascending and descending stairs and curbs.

Recalls

DateFirmReason
2025-04-03WANDERCRAFT SASPotential for exoskeleton to lose lateral balance and cause patient to fall.
2020-02-28Argo Medical Technologies LtdReWalk 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
2017-08-14Argo Medical Technologies LtdFirm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.