FDA.reportPublic FDA data

NA

Primary DI
06944413808164
Brand
NA
Company
Edan Instruments, Inc.
Model
TM-400 Treadmill
Published
2017-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
06944413808164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413808164069444138081646944413808164

GMDN Terms#

Term, Definition table
TermDefinition
Stress exercise trolleyA cart that accommodates an ergometer (e.g., a static bicycle or treadmill) and the necessary equipment to measure metabolic energy expenditure and cardiovascular/respiratory function during exercise. This trolley (cart) is used for periodic assessment of the patient's progress in cardiac and pulmonary rehabilitation programs to determine energy expenditure levels.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
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
06944413805323SpO2 SensorSpO2 Finger Sensor, adult, 1m, reusable2016-09-01
06944413805361SpO2 SensorSH4 Adult Silicone Soft-tip2016-09-01
06944413805385SpO2 SensorSH5 pediatric Silicone Soft-tip2016-09-01
06944413805422SpO2 SensorSHD-P, pediatric, disposable2016-09-01
06944413805439SpO2 SensorSHD-A , adult, disposable2016-09-01
06944413807075iT20 SpO2 extension cableiT20 SpO2 extension cable, 0.65m2017-02-22
06944413809468Connection Cable01.13.0374772026-10-15
06944413835153Telemetry MonitoriT302026-08-26
06944413835214Telemetry MonitoriT502026-08-26
06944413844919SE-1202 Series ElectrocardiographSE-1202E2026-07-21
06944413847422SE-1202 Series ElectrocardiographSE-12022026-07-21
06944413817210Connection Cable01.57.4721782026-05-19
06944413817234 Connection Cable01.57.4722162026-05-19
06944413820050EMG/Stimulation sensor01.57.4726242026-05-19
06944413820074EMG/Stimulation sensor01.57.4726312026-05-19
06944413825475Connection Cable01.57.4722812026-05-19
06944413825482Connection Cable01.57.4723812026-05-19
06944413834026EMG/Stimulation sensor01.57.4726252026-05-19
06944413834736EMG/Stimulation sensor01.57.472623 2026-05-19
06944413866133Stimulation SystemPR362026-05-15

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