Indego Therapy

GUDID B168501110001

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: B168501110001
• NIH Device Record Key: ee7ed7cb-8249-48c6-83e5-7581a53b2215
• 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: (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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B168501110001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173530

FDA Product Code

• PHL: Powered Exoskeleton

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-09
• Device Publish Date: 2025-07-01

On-Brand Devices [Indego Therapy]

• M704501110001: Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walkin
• B168501110001: Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walkin