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 ID: M704501110001
• NIH Device Record Key: 9f82eedc-48bd-4c54-b91b-7f1f82e79ef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indego Therapy
• Version Model Number: 501-110-001
• Company DUNS: 190152921
• Company Name: EKSO BIONICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: 844-846-3346
• Email: support.indego@parker.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com
• Phone: (510) 984-1761
• Email: support.indego@eksobionics.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 11.6 KiloPascal and 101 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 78 KiloPascal and 101 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 31 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M704501110001 [Primary]

FDA Product Code

• PHL: Powered Exoskeleton

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-23
• Device Publish Date: 2018-08-27

Devices Manufactured by EKSO BIONICS, INC.

• M704501100000 - Indego: 2023-10-23 Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
• M704501110001 - Indego Therapy: 2023-10-23Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
• M704501110001 - Indego Therapy: 2023-10-23 Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individu
• B168EKSOGT0 - EksoGT: 2022-03-11 EKSO BIONICS SYSTEM, Ekso GT
• B168EKSONR0 - EksoNR: 2022-03-11 EKSO BIONICS SYSTEM, Ekso NR
• B168EKSOUE0 - EksoUE: 2022-03-11 EKSO BIONICS SYSTEM, Ekso UE
• B1431200000 - Ekso: 2018-03-29 The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is w