FDA.reportPublic FDA data

OMEGO

Primary DI
09120077180083
Brand
OMEGO
Company
tyromotion GmbH
Model
1
Device description
The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
Published
2022-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120077180083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120077180083091200771800839120077180083

GMDN Terms#

Term, Definition table
TermDefinition
Treadmill/elliptical gait rehabilitation systemAn assembly of electrically-powered devices designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. It primarily consists of a speed-regulated treadmill or elliptical to facilitate gait; an overhead patient support assembly with pulleys, harness, and straps to unload patient weight; a robotic orthosis system attached to the patient's legs individually, or in the form of pedals, to guide leg movements; side-mounted rails for patient support; an operator control unit to regulate speed/elevation and display related data; and sometimes patient incentive features.

Regulatory Flags#

DUNS number
301726803
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120077180038TyrostationR12026-03-13
09120077180212AMADEOR72026-03-12
09120077180236DIEGOR22026-03-12
09120077180243OMEGOR12026-03-12
09120077180250LEXOG12026-03-12
09120077180045TYMO 52022-09-18
09120077180052PABLO System42022-09-18
09120077180106PABLO Lower Extremity42022-09-18
09120077180113ARYS me32022-09-18
09120077180120ARYS pro32022-09-18
09120077180144TYMO 62024-06-18
09120077180151PABLO52024-06-18
09120077180014AMADEO72022-09-18
09120077180021DIEGO22022-09-18
09120077180069MYRO12022-09-18
09120077180076LEXOR12021-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
06976287180787Active Passive Trainer for Upper and Lower LimbsGuangzhou Longest Medical Technology Co., Ltd.BXB2026-04-14
00888912267588CHATTANOOGADJO, LLCBXB2026-03-31
00888912267618CHATTANOOGADJO, LLCBXB2026-03-31
00888912267625CHATTANOOGADJO, LLCBXB2026-03-31
00888912267632CHATTANOOGADJO, LLCBXB2026-03-31
04041925006230THERA-Trainer bemomedica - Medizintechnik GmbHBXB2026-03-16
04041925006247THERA-Trainer bemomedica - Medizintechnik GmbHBXB2026-03-16
09120077180212AMADEOtyromotion GmbHBXB2026-03-12
09120077180236DIEGOtyromotion GmbHBXB2026-03-12
09120077180243OMEGOtyromotion GmbHBXB2026-03-12
04041925006254THERA-Trainer toromedica - Medizintechnik GmbHBXB2025-12-16
04041925006261THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006278THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006285THERA-Trainer toro medica - Medizintechnik GmbHBXB2025-12-16
04041925006308OmniCycle® Revo medica - Medizintechnik GmbHBXB2025-12-16
04041925006315OmniCycle® Revomedica - Medizintechnik GmbHBXB2025-12-16
EJKP100004088A0Recovery 7200 PFJK-Products GmbHBXB2025-12-10
EJKP100004192A0Red Wave Recovery JK-Products GmbHBXB2025-10-30
00860005350827AMBLENextstep Robotics, Inc.BXB2025-09-29
04041925006193THERA-Trainer toromedica - Medizintechnik GmbHBXB2025-09-04
04041925006179THERA-Trainer tigomedica - Medizintechnik GmbHBXB2025-08-28