FDA.reportPublic FDA data

GaitBetter

Primary DI
B914GBD20
Brand
GaitBetter
Company
GOLDENGAIT LTD
Model
2.0
Published
2020-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B914GBD20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Standard treadmill, poweredA mains electricity (AC-powered) device designed to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness. It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) on which the patient exercises that can be set to rotate at varying speeds, electric motors, and a control unit (to regulate belt speed/elevation, display related data, and activate an emergency stop). It will typically incorporate front and side-mounted rails to allow patients to steady themselves while in motion.

Contacts#

Phone, Email table
PhoneEmail
+972795729835info@gaitbetter.com

Regulatory Flags#

DUNS number
531866455
Device count
1
Premarket exempt
true
Serial number
true

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
07290019733829BalanceTutorMEDITOUCH LTDIOL2023-06-21
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
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