DEVICE: ReWalk(TM) Rehabilitaiton (00861803000327)

Device Identifier (DI) Information

ReWalk(TM) Rehabilitaiton
50-30-0001
In Commercial Distribution

REWALK ROBOTICS LTD
00861803000327
GS1

1
533320867 *Terms of Use
Powered Exoskeleton - rehabilitation institution use
CLOSE

Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58943 Programmable ambulation exoskeleton, clinical
A battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; it is typically strapped to the legs over clothing. It is intended for multiple-patient use, in a controlled clinical setting (e.g., gait lab, rehabilitation centre) under healthcare professional supervision.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PHL Powered Exoskeleton
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN130034 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

d5127bca-bdfc-4fbb-8c9b-ec0943c19799
July 06, 2018
3
September 08, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1 (508) 251-1154
contact@rewalk.com
CLOSE