ReWalk 7 Personal Exoskeleton

Basic Information

• Brand Name: ReWalk 7 Personal Exoskeleton
• Primary DI: 00860001744514
• Version / Model: ReWalk 7
• Catalog Number: 50-20-0005
• Company Name: LIFEWARD LTD
• Labeler DUNS: 533320867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-15
• Public Version: 1
• Public Version Date: 2025-04-23
• Public Version Status: New
• Public Device Record Key: 55ce17ed-11cc-4100-8f96-8417590e557b

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHL	Powered Exoskeleton	Physical Medicine	890.3480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60788	Programmable ambulation exoskeleton, home-use	A battery-powered, pre-programmed, lower-limb orthosis system intended to enable a patient with a walking disability resulting from spinal cord injury to perform routine ambulatory functions (e.g., stand, walk, ascend and descend stairs); it may also be used to help promote intrinsic motor function. It is typically strapped to the patient over clothing and includes an exoskeleton structure made of metal, with electric motors, mechanical actuators and sensors, an on-board computer, and controls. It is intended for single-patient use, typically outside of a controlled setting following completion of training under professional supervision.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001744514	GS1