EksoNR EKSONR

GUDID B168EKSONR0

EKSO BIONICS SYSTEM, Ekso NR

EKSO BIONICS, INC.

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• Primary Device ID: B168EKSONR0
• NIH Device Record Key: bb2be74d-eb3b-4b50-a82f-7a5247bfaa81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EksoNR
• Version Model Number: EKSONR
• Catalog Number: EKSONR
• Company DUNS: 190152921
• Company Name: EKSO BIONICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B168EKSONR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200574

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: 2022-03-11
• Device Publish Date: 2022-03-03

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: 2023-10-23 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: 2022-03-11EKSO BIONICS SYSTEM, Ekso NR
• 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