ReWalk(TM) Personal 6.0

Basic Information

• Brand Name: ReWalk(TM) Personal 6.0
• Primary DI: 00861803000303
• Version / Model: 50-20-0004
• Company Name: REWALK ROBOTICS LTD
• Labeler DUNS: 533320867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cc6f7ee4-9809-4341-a609-56584c6bebab

Device Description

Powered Exoskeleton - community use

Device Characteristics

• Single Use: No
• 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: No
• 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	00861803000303	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160987	000