DEVICE: Indego (M704501100000)
Device Identifier (DI) Information
Indego
501-100-000
In Commercial Distribution
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution
EKSO BIONICS, INC.
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PHL | Powered Exoskeleton |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152416 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 0 and 31 Degrees Celsius |
Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 78 and 101 KiloPascal |
Storage Environment Temperature: between -20 and 50 Degrees Celsius |
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 11.6 and 101 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
91f6cd0d-a247-42b8-9fec-e3f175140b80
October 27, 2023
5
September 15, 2016
October 27, 2023
5
September 15, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(510) 984-1761
support.indego@eksobionics.com
support.indego@eksobionics.com