ReWalk(TM) Rehabilitaiton

GUDID 00861803000327

Powered Exoskeleton - rehabilitation institution use

REWALK ROBOTICS LTD

Programmable ambulation exoskeleton, clinical
Primary Device ID00861803000327
NIH Device Record Keyd5127bca-bdfc-4fbb-8c9b-ec0943c19799
Commercial Distribution StatusIn Commercial Distribution
Brand NameReWalk(TM) Rehabilitaiton
Version Model Number50-30-0001
Company DUNS533320867
Company NameREWALK ROBOTICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (508) 251-1154
Emailcontact@rewalk.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861803000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHLPowered Exoskeleton

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-08

Devices Manufactured by REWALK ROBOTICS LTD

00860001744507 - ReStore2019-10-24 The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions
00861803000303 - ReWalk(TM) Personal 6.02018-07-06 Powered Exoskeleton - community use
00861803000327 - ReWalk(TM) Rehabilitaiton2018-07-06Powered Exoskeleton - rehabilitation institution use
00861803000327 - ReWalk(TM) Rehabilitaiton2018-07-06 Powered Exoskeleton - rehabilitation institution use
00861803000310 - ReWalk(TM) Personal2018-03-29 Powered exoskeleton - community use

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