FDA.reportPublic FDA data

Lode B.V.

Primary DI
08717524640088
Brand
Lode B.V.
Company
Lode B.V.
Model
938903
Device description
938903 Valiant 2 rehab XL
Published
2017-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
08717524640088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717524640088087175246400888717524640088

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
407774181
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717524641085Lode B.V.9659112026-06-01
08717524641092Lode B.V.9659212026-06-01
08717524640392Lode B.V.9379012017-05-09
08717524640064Lode B.V.9389002017-05-09
08717524640071Lode B.V.9389012017-05-10
08717524640095Lode B.V.9389042017-05-10
08717524640101Lode B.V.9389052017-05-10
08717524640118Lode B.V.9389062017-05-11
08717524640156Lode B.V.9389022017-05-11
08717524640163Lode B.V.9349302017-05-11
08717524640170Lode B.V.9349002017-05-11
08717524641054Lode B.V.9259002019-08-09
08717524641061Lode B.V.9259092019-08-09
08717524640026Lode B.V.9609002017-05-08
08717524640033Lode B.V.9609012017-05-09
08717524640057Lode B.V.9609122017-05-09
08717524640187Lode B.V.9299002017-05-11
08717524640484Lode B.V.9679002018-02-01
08717524640491Lode B.V.9679022018-02-01
08717524640507Lode B.V.9679032018-02-01

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Primary DI, Brand, Company table
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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
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00860003532003ActiveStepSIMBEX LLCIOL2020-05-01
00860003532010ActiveStepSIMBEX LLCIOL2020-05-01
00860003532027ActiveStepSIMBEX LLCIOL2020-05-01
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04050588000080mercury® medh/p/cosmos sports & medical gmbhIOL2020-01-07
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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