FDA.reportPublic FDA data

BalanceTutor

Primary DI
07290019733829
Brand
BalanceTutor
Company
MEDITOUCH LTD
Model
HMBT100 A
Device description
Reactive response treadmill trainer
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IOLTreadmill, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOLTreadmill, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290019733829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019733829072900197338297290019733829

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display rehabilitation system, non-supportive, clinicalAn assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
649792983
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019733003HandTutorHMHT1001L2023-06-21
07290019733836TutorCart WorkStationSUB-42-01-01_A2023-06-21
07290019733843TutorCart WorkStationHMTW100A2023-06-21
072900197338503DTutor StationHMTS100A2023-06-21
072900197338673DTutorHM3DT100B2023-06-21
07290019733874LegTutorHMLT100-R2023-06-21
07290019733881LegTutorHMLT100-L2023-06-21
07290019733898ArmTutorHMAT100-R2023-06-21
07290019733904ArmTutorHMAT100-L2023-06-21
07290019733911HandTutorHMHT1005R2023-06-21
07290019733928HandTutorHMHT1005L2023-06-21
07290019733935HandTutorHMHT1004R2023-06-21
07290019733942HandTutorHMHT1004L2023-06-21
07290019733959HandTutorHMHT1003R2023-06-21
07290019733966HandTutorHMHT1003L2023-06-21
07290019733973HandTutorHMHT1002R2023-06-21
07290019733980HandTutorHMHT1001R2023-06-21
07290019733997HandTutorHMHT1002L2023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00718175006009Reactive Step Trainer 115VSPORT MEDICAL TECHNOLOGY INC.IOL2024-05-06
G407870C0MedisoftMEDISOFT RAM ITALIA SRLIOL2024-01-18
G407870S0MedisoftMEDISOFT RAM ITALIA SRLIOL2024-01-18
G407870A0MedisoftMEDISOFT RAM ITALIA SRLIOL2023-12-05
00850040235005GaitKeeperMobility Research, Inc.IOL2023-07-14
00860176000606TrackmasterFull Vision, Inc.IOL2022-12-30
00860176000613TrackmasterFull Vision, Inc.IOL2022-12-30
00860176000620TrackmasterFull Vision, Inc.IOL2022-12-30
00860176000637TrackmasterFull Vision, Inc.IOL2022-12-30
00860176000668T2100-STFull Vision, Inc.IOL2022-12-30
00860176000675T2100-STFull Vision, Inc.IOL2022-12-30
B914GBD20GaitBetterGOLDENGAIT LTDIOL2020-05-27
00860003532003ActiveStepSIMBEX LLCIOL2020-05-01
00860003532010ActiveStepSIMBEX LLCIOL2020-05-01
00860003532027ActiveStepSIMBEX LLCIOL2020-05-01
04050588000059stratos® lt medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000066stratos® medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000073mercury® lt medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000080mercury® medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000295locomotion® 150/50 E medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000493stellar® lt medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000509stellar® medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000516quasar® lt medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000523quasar® medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000554pulsar® lth/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000561pulsar® lt 3ph/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000578pulsar®h/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000585pulsar® 3ph/p/cosmos sports & medical gmbhIOL2020-01-07
04050588001506locomotion® 150/50 DE medh/p/cosmos sports & medical gmbhIOL2020-01-07
04050588001544quasar® med 3p h/p/cosmos sports & medical gmbhIOL2020-01-07