FDA.reportPublic FDA data

pulsar® lt

Primary DI
04050588000554
Brand
pulsar® lt
Company
h/p/cosmos sports & medical gmbh
Model
cos30004va01
Catalog number
cos30004va01
Published
2020-01-07
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
04050588000554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050588000554040505880005544050588000554

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary stress test treadmillAn electrically-powered device designed to be used as a component of a stress test system that permits the evaluation of a patient's physiologic response to physical stress (e.g., workload testing of the cardiac and/or pulmonary disorders/function). It is designed for walking, jogging, or running on a moving belt that facilitates physical exercise while the patient remains on the spot (i.e., treadmill). It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) that rotates at varying speeds and elevation, electric motors, and controls. It will typically incorporate front and side-mounted rails to allow the user to steady themselves.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341362614
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
04050588000059stratos® lt medcos30000va05cos30000va052020-01-07
04050588000066stratos® medcos30000va06 cos30000va06 2020-01-07
04050588000073mercury® lt medcos30000va07cos30000va072020-01-07
04050588000080mercury® medcos30000va08 cos30000va08 2020-01-07
04050588000295locomotion® 150/50 E medcos30001va01 cos30001va01 2020-01-07
04050588000493stellar® lt medcos30003va17cos30003va172020-01-07
04050588000509stellar® medcos30003va18cos30003va182020-01-07
04050588000516quasar® lt medcos30003va19cos30003va192020-01-07
04050588000523quasar® medcos30003va20cos30003va202020-01-07
04050588000561pulsar® lt 3pcos30004va02cos30004va022020-01-07
04050588000578pulsar®cos30004va03 cos30004va03 2020-01-07
04050588000585pulsar® 3pcos30004va04 cos30004va04 2020-01-07
04050588001506locomotion® 150/50 DE medcos30001-01va02 cos30001-01va02 2020-01-07
04050588001544quasar® med 3p cos30003va26cos30003va262020-01-07
04050588001612venus® 200/75cos30005-01va05cos30005-01va052020-01-07
04050588001629venus® 200/75rcos30005-01va06cos30005-01va062020-01-07
04050588001674venus® 200/100cos30006-01va05cos30006-01va052020-01-07
04050588001681venus® 200/100rcos30006-01va06 cos30006-01va06 2020-01-07
04050588001735saturn® 250/75cos30007-01va05cos30007-01va052020-01-07
04050588001742saturn® 250/75rcos30007-01va06 cos30007-01va06 2020-01-07

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
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