Indego

Basic Information

• Brand Name: Indego
• Primary DI: M704501100000
• Version / Model: 501-100-000
• Company Name: EKSO BIONICS, INC.
• Labeler DUNS: 190152921
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 5
• Public Version Date: 2023-10-27
• Public Version Status: Update
• Public Device Record Key: 91f6cd0d-a247-42b8-9fec-e3f175140b80

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHL	Powered Exoskeleton	Physical Medicine	890.3480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M704501100000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152416	000

Storage Conditions

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