FDA.reportPublic FDA data

THERA-Trainer bemo

Primary DI
04041925002812
Brand
THERA-Trainer bemo
Company
medica - Medizintechnik GmbH
Model
01.XX.XX
Published
2023-10-23
Public version status
Update
Distribution status
Not 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
04041925002812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041925002812040419250028124041925002812

GMDN Terms#

Term, Definition table
TermDefinition
Continuous passive motion joint exerciserA mains electricity (AC-powered) device designed to continuously move one or more joints (shoulder, elbow, wrist, hand/fingers, hip, knee, ankle, and/or feet/toes) without patient assistance during continuous passive motion (CPM) exercise therapy. It typically consists of a motorized carriage with pads and straps to hold and support the limb/digit, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; it may additionally be intended to provide active resistance. It is typically intended to stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and/or coordination training.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328011325
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04041925006339PHS - XSGBS 01.YY.ZZA008-6852026-05-13
04041925006346PHS - SGBS 01.YY.ZZA008-6862026-05-13
04041925006353PHS - MGBS 01.YY.ZZA008-6872026-05-13
04041925006360PHS - LGBS 01.YY.ZZA008-6882026-05-13
04041925006377PHS - XLGBS 01.YY.ZZA008-6892026-05-13
04041925006117PHS - XSGBS 01.YY.ZZA008-6852024-11-14
04041925006124PHS - SGBS 01.YY.ZZA008-6862024-11-14
04041925006131PHS - MGBS 01.YY.ZZA008-6872024-11-14
04041925006148PHS - LGBS 01.YY.ZZA008-6882024-11-14
04041925006155PHS - XLGBS 01.YY.ZZA008-6892024-11-14
04041925006230THERA-Trainer bemo02.YY.ZZA006-8772026-03-16
04041925006247THERA-Trainer bemo02.YY.ZZA006-8782026-03-16
04041925006254THERA-Trainer toro01.05.ZZ2025-12-16
04041925006261THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006278THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006285THERA-Trainer toro 01.05.ZZ2025-12-16
04041925006308OmniCycle® Revo 01.05.ZZ2025-12-16
04041925006315OmniCycle® Revo01.05.ZZ2025-12-16
04041925006193THERA-Trainer toro01.YY.XX2025-09-04
04041925006179THERA-Trainer tigo04.XX.XX2025-08-28

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