PABLO System

GUDID 09120077180052

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

tyromotion GmbH

Virtual-display rehabilitation system, non-supportive, clinical
Primary Device ID09120077180052
NIH Device Record Keyef44eeb8-6b22-4fd6-9a8d-fe39025c1901
Commercial Distribution Discontinuation2026-03-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePABLO System
Version Model Number4
Company DUNS301726803
Company Nametyromotion GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120077180052 [Primary]

FDA Product Code

BXBExerciser, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-03-13
Device Publish Date2022-09-18

Devices Manufactured by tyromotion GmbH

09120077180038 - Tyrostation2026-03-23
09120077180212 - AMADEO2026-03-20 The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervou
09120077180236 - DIEGO2026-03-20 DIEGO is a robotic arm-shoulder therapy system for the rehabilitation of patients with limited arm function.
09120077180243 - OMEGO2026-03-20 The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
09120077180250 - LEXO2026-03-20 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 System2026-03-13PABLO System is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
09120077180052 - PABLO System2026-03-13 PABLO System is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily
09120077180106 - PABLO Lower Extremity2026-03-13 The PABLO Lower Extremity system is a sensor-based therapy system for gait assessment and movement feedback.

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.