ARYS me

GUDID 09120077180113

ARYS me is intended for over-the-counter use for self-directed management of arm rehabilitation without specific treatment or treatment recommendations.

tyromotion GmbH

Biomechanical function analysis/rehabilitation software

• Primary Device ID: 09120077180113
• NIH Device Record Key: c353f093-f9f7-46ee-8133-d62c7a6cbe34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARYS me
• Version Model Number: 3
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120077180113 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2024-02-05
• Device Publish Date: 2022-09-18

Devices Manufactured by tyromotion GmbH

• 09120077180038 - Tyrostation: 2026-03-23
• 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.