AMADEO

GUDID 09120077180212

The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervous system, caused by typical indications such as stroke or traumatic brain injury.

tyromotion GmbH

Virtual-display rehabilitation system, powered-support, upper-limb

• Primary Device ID: 09120077180212
• NIH Device Record Key: ec8e827a-c4dd-4e67-8d7b-645091c2aa1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMADEO
• Version Model Number: R7
• Company DUNS: 301726803
• Company Name: tyromotion GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120077180212 [Primary]

FDA Product Code

• BXB: Exerciser, Powered

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: 2026-03-20
• Device Publish Date: 2026-03-12

Devices Manufactured by tyromotion GmbH

• 09120077180038 - Tyrostation: 2026-03-23
• 09120077180212 - AMADEO: 2026-03-20The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervous system, caused by typical indications such as stroke or traumatic brain injury.
• 09120077180212 - AMADEO: 2026-03-20 The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervou
• 09120077180236 - DIEGO: 2026-03-20 DIEGO is a robotic arm-shoulder therapy system for the rehabilitation of patients with limited arm function.
• 09120077180243 - OMEGO: 2026-03-20 The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
• 09120077180250 - LEXO: 2026-03-20 The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to wal
• 09120077180045 - TYMO: 2026-03-13 The TYMO system is a modern monitoring and therapy device for the rehabilitation of patients suffering from motoric dysfunctions
• 09120077180052 - PABLO System: 2026-03-13 PABLO System is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily
• 09120077180106 - PABLO Lower Extremity: 2026-03-13 The PABLO Lower Extremity system is a sensor-based therapy system for gait assessment and movement feedback.