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510(k) Data Aggregation
K Number
K241822Device Name
ReWalk® 7 Personal Exoskeleton (50-20-0005)
Manufacturer
ReWalk Robotics Ltd. DBA Lifeward
Date Cleared
2025-03-12
(261 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
ReWalk Robotics Ltd. DBA Lifeward
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReWalk® 7 Personal Exoskeleton fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions in home and community settings with supervision of a specially certified Companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in accordance with the User assessment and training certification program. The ReWalk 7 is intended for including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs.
Device 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.
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