tyromotion GmbH

Address:TYROMOTION GMBH,Graz Steiermark,AT

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Exerciser, Powered (BXB) (7) Exerciser, Non-Measuring (ION) (2) System, Isokinetic Testing And Evaluation (IKK) (1)

Premarket Exempt

Yes

Clear

AMADEO - 09120077180014 Catalog Number :

Device Description : The AMADEO system is intended for robot-supported finger-hand therapy of patient 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.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

DIEGO - 09120077180021 Catalog Number :

Device Description : DIEGO is a robotic arm-shoulder therapy system for the rehabilitation of patient DIEGO is a robotic arm-shoulder therapy system for the rehabilitation of patients with limited arm function.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

TYMO - 09120077180045 Catalog Number :

Device Description : The TYMO system is a modern monitoring and therapy device for the rehabilitation The TYMO system is a modern monitoring and therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

PABLO System - 09120077180052 Catalog Number :

Device Description : PABLO System is a modern therapy device for the rehabilitation of patients suffe PABLO System is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

MYRO - 09120077180069 Catalog Number :

Device Description : The MYRO therapy system is generally used for neurological rehabilitation of the The MYRO therapy system is generally used for neurological rehabilitation of the upper extremities.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

LEXO - 09120077180076 Catalog Number :

Device Description : The LEXO is a mechatronic therapy system for body weight-supported gait rehabili The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.

Device Class : 2

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : No

Device Count : 1

OMEGO - 09120077180083 Catalog Number :

Device Description : The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patient The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

PABLO Lower Extremity - 09120077180106 Catalog Number :

Device Description : The PABLO Lower Extremity system is a sensor-based therapy system for gait asses The PABLO Lower Extremity system is a sensor-based therapy system for gait assessment and movement feedback.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : No

Device Count : 1

ARYS me - 09120077180113 Catalog Number :

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

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : ION

Prescription Use : No

Device Count : 1

ARYS pro - 09120077180120 Catalog Number :

Device Description : ARYS pro is intended to track and organize patient health and activity informati ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.

Device Class : 1

Duns Number: 301726803

Premarket Exempt : Yes

Product Code : ION

Prescription Use : No

Device Count : 1

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