FDA.reportPublic FDA data

T2100

Primary DI
00840682106023
Brand
T2100
Company
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Model
Treadmill
Published
2017-07-25
Public version status
Update
Distribution status
Not 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
00840682106023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682106023008406821060238406821060230840682106023

GMDN Terms#

Term, Definition table
TermDefinition
Stress test treadmillAn electrically-powered (AC-powered) device that is typically 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
784985108
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

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00840682140935N/AB1X5-F22104800-0012020-11-16
00195278620873MAC72119091-0012026-03-31
00840682122504N/A420915-0692016-12-14
00840682122528N/A420915-0112016-12-13
00195278507037Mac-LabAltiX2300000-0032026-03-26
00195278507044CardioLabAltiX2300000-0042022-05-01
00195278507051ComboLabAltiX2300000-0052022-05-01
00195278507525MLCL Client SoftwareAltiX58896052022-05-01
00195278516015MLCL UpgradeAltiX58965972022-05-01
00195278330413Portrait CVA01CVA0158637212023-09-01
00195278341129Portrait CSS01CSS0158708572023-09-01
00840682104814NA2017098-0072016-07-22
00840682104845NA2017098-0032016-07-22
00840682104852NA2017098-0012016-07-22
00840682104869NA2017098-0052016-07-22
00840682109260CARESCAPETelemetry Server V42016-06-10
00840682104784N/APatient Data Module2016-05-27
00840682108775CARESCAPETelemetry Server v4 upgrade2016-06-10

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04050588000578pulsar®h/p/cosmos sports & medical gmbhIOL2020-01-07
04050588000585pulsar® 3ph/p/cosmos sports & medical gmbhIOL2020-01-07
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