Indego Therapy

GUDID M704501110001

Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.

EKSO BIONICS, INC.

Programmable ambulation exoskeleton, clinical
Primary Device IDM704501110001
NIH Device Record Key9f82eedc-48bd-4c54-b91b-7f1f82e79ef6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIndego Therapy
Version Model Number501-110-001
Company DUNS190152921
Company NameEKSO BIONICS, INC.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone844-846-3346
Emailsupport.indego@parker.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com
Phone(510) 984-1761
Emailsupport.indego@eksobionics.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius
Storage Environment Atmospheric PressureBetween 11.6 KiloPascal and 101 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Handling Environment Atmospheric PressureBetween 78 KiloPascal and 101 KiloPascal
Handling Environment HumidityBetween 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 31 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM704501110001 [Primary]

FDA Product Code

PHLPowered Exoskeleton

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-23
Device Publish Date2018-08-27

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