FDA.reportPublic FDA data

Gait Trainer 3

Primary DI
00718175005415
Brand
Gait Trainer 3
Company
SPORT MEDICAL TECHNOLOGY INC.
Model
950-401
Catalog number
950-401
Device description
Gait Trainer 3, 230 VAC
Published
2018-04-30
Public version status
Update
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
00718175005415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175005415007181750054157181750054150718175005415

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145217304
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
00718175002407Biostep 2, 100-240 VAC950-2402024-05-06
00718175006009Reactive Step Trainer 115V950-6002024-05-06
00718175001462Biodex950-146950-1462023-08-02
00718175001486Biodex950-148950-1482023-08-02
00718175005606Sit2Stand950-560950-5602023-07-31
00718175004302VibroTactile950-4302023-07-19
00718175004807NxSTEP945-480945-4802019-05-15
00718175004845NxSTEP950-484950-4842019-05-15
00718175005705MOBILITY ASSIST950-570950-5702019-06-10
00718175004852NxSTEP950-485950-4852019-04-30
00718175000038BALANCE SD950-440950-4402018-06-30
00718175000045BALANCE SD950-441950-4412018-06-30
00718175000052BALANCE SD950-444950-4442018-06-30
00718175000120BIOSWAY 950-460950-4602018-06-30
00718175004005System 4 Pro850-000850-0002017-12-18
00718175004050MJS System 3 Upgrade850-820850-8202017-12-18
00718175004067MJS System 3 Upgrade850-822850-8222018-08-10
00718175004203System 4 Quick Set840-000840-0002017-12-18
00718175004401System 4 MVP852-000852-0002017-12-18
00718175005408Gait Trainer 3950-400950-4002018-04-15

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
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